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Bard Power Port defects
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jebppr posted:

Update on my Bard Power Port crisis: After 29 days of chemo over 4 years of fighting leukemia, my burned out veins became too painful so I had a port implanted Jan. 12, 2011. It was a Bard Power Port, Lot REUJ0764, REF 1808000, serial # 3513, made by Bard Access Systems. It was horrible. It never worked correctly. It was defective in every way imaginable. The infusion techs gave up and refused to try to access it again. It usually could not be accessed nor flushed-could not get blood return but then when the access line was removed, it literally sprayed blood & bleeding was hard to stop resulting in massive bruising and swelling. The catheter was apparently defective since it kinked in a gentle curve and was 100% blocked per the x-ray. Bard refuses to discuss it of course. So on June 8, 2011, it had to be removed. The surgeon who removed it is not the one who implanted it. The surgeon who implanted it would not return my calls after I said it was defective. Seems he is real cozy with Bard. So I fired him! The surgeon who removed it stated in writing that he tested it and found a hole in the catheter at mid length! I asked that surgeon if any of the many large IV bags of chemicals could be floating around in my chest cavity. He replied: "you need to get an opinion on that". Real scary! I don't know yet what the possible medical consequences of leakage through that large hole could be except that it is causing extreme anxiety. I asked the surgeon who implanted it, my oncologist, and nurses but got no response. My last chemo drug was a fairly new one. The catheter is discolored in the vicinity of the hole which indicates possible adverse reaction between my meds and the catheter where they were blocked. My next crisis will be how to take future chemo if needed. I don't think I can ever live with another port in my body! I, like many of you, am seeking a legal team. If you're having problems with your port, please file an FDA complaint (FDA Form 3500 on line) as I did to prevent others having this horrific experience. Please share your experiences here also. Jim (jebp3)
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hs30540 responded:
My wife has a Bard Power Port. can't get a blood return when doing monthly flush. Bard says needle is too short. Infusion Lab and doctor at hospital said use 3/4" needle, Bard now says use 1" needle minimum. Any one know if the 1" needles make it work better?
 
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susiemargaret replied to hs30540's response:
hello, H --

do the instructions for the power port specify what bard now says is the correct length for the needle?

the form (no. 3500) for filing a complaint with the food and drug administration (FDA) can be accessed thru http://www.webmd.com/fda/your-guide-reporting-problems-fda . look in the second set of info in the chart titled "quick-reference chart for reporting problems."

in the alternative, from the FDA website, you can get --

-- two guides that discuss how to report a problem with a medical device (you should look at both, because they cover different topics), http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049087.htm and http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm ;

-- general instructions for reporting, http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm ; and

-- the form (no. 3500) for on-line reporting, https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm , and its specific instructions, http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/UCM082725.pdf -online.htm ; or

-- the form (no. 3500) for download for a paper copy to be faxed (800/332-0178) or mailed (MEDWATCH, FDA safety information and adverse event reporting program, food and drug administration, 5600 fishers lane, rockville, MD, 20852-9787), http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/UCM082725.pdf , and and its specific instructions, click on "general instructions" in the yellow box very near the top of the page, http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/UCM082725.pdf .

finally, you can call the FDA (800/332-1088) or a state complaint coordinator (list of states and phone numbers is at http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm ), and have someone take all of your info by phone. however, i do not recommend that you use the phone for reporting, because you don't have control over what is written down (everyone makes mistakes, even FDA employees!) and there is the risk of miscommunication if the FDA employee doesn't hear something correctly. plus if you use the phone, you have no written record of what you submitted.

on the topic of bard power port problems (see PS), this community has several threads that you might want to have a look at --

-- http://forums.webmd.com/3/chronic-disease-and-disability-exchange/forum/594/16#16 ,

-- http://forums.webmd.com/3/chronic-disease-and-disability-exchange/forum/817/1?@guest ,

-- http://forums.webmd.com/3/chronic-disease-and-disability-exchange/forum/875/0?@guest , and

-- http://forums.webmd.com/3/chronic-disease-and-disability-exchange/forum/971 .

i send caring thoughts to you and your wife and hope that she will have no more problems with her port device.

-- susie margaret

PS -- you can see typical adverse-event reports on bard power port problems (be sure that the reported items have the same name and model number as whatever you want to report if you want to show a pattern) at --

-- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=918890&utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=(bard , and

-- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1589585&utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=(bard .
what good is gold, or silver too, if your heart's not good and true -- hank williams, sr.
 
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ciaranani replied to hs30540's response:
Dear hs30540,
My experience has been similar to yours. So many times when they come to flush my port, they can't get blood return either. They can usually flush it but can't draw blood. I am having surgery tomorrow to have my THIRD PowerPort placed because this one doesnt work. It is totally disgusting that I have to have 3 ports in 3 yrs because Bard can't get it together to remedy the problems they are having with their ports.
I have typically had the best results using a 1" needle. The literature only says to use a "huber, non-coring needle from 3/4" to 1 1/2". My nurses usually have the best luck using the 1". The shorter needles arent long enough to get thru the scar tissue and into the port diaphragm..
Hopefully this will help you. I see that you posted this one month ago so maybe by now you have received an answer.
Blessings to you,
Ciaranani
 
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susiemargaret responded:
hello, all --

i have compiled a list of all of the threads i could find on bard power ports at http://forums.webmd.com/3/chronic-disease-and-disability-exchange/forum/979 . looking at these will give you a good idea of what problems are out there plus contact info for several of the people who have had problems such as yours.

i have also compiled a summary of the procedures for making a complaint to the FDA, http://forums.webmd.com/3/chronic-disease-and-disability-exchange/forum/980 (with extensive borrowing from one or two of the messages here, thank you very much!).

as far as I can tell, these two lists are accurate up to july 4, 2012. I hope they are helpful to you.

-- susie margaret
what good is gold, or silver too, if your heart's not good and true -- hank williams, sr.
 
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schoolboardlady replied to hs30540's response:
My chemo nurse used a one inch needle because she said my port is inserted more deeply. It worked fine when the longer needle is used. My chemo ended November 8th and I had the port removed on December 20th. Now, I'm just recovering my upper body strength and muscles after 10 months of the port. I seem to have some scar tissue around where the port was inserted, touching my brachial nerve. Hoping my brachial nerve finds peace within the muscle bundle and pain will gradually diminish.


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