I am wondering if any institution has any problems with a well known brand of 5Fr Power PICC where the catheter is coming away from the catheter hub. At our insitution we have had 10 patients who have had to have their catheters exchanged for this problem. The company, without naming the company says no other problems have been reported. Each time, it is exactly in the same place and if you have had the problem - this will make sense to you. These problems started showing up in March 2011 and now our institution have stopped using this brand of catheter until a feasible explanation can be given. The fault presents itself anywhere from 17-70 days dwell time. Has anyone had any similar problems? I would be interested to communicate privately if this problem sounds familiar.
I cannot address you questions directly but can recommend a few other things to check. For the brand you are using, how many power injection cycles can it tolerate? You will find this information usually in the instructions for use. Have these patients exceeded that number of power injections with the catheter that have this problem?
Who in the company is telling you that no one else is having this problem? This is a common statement from local sales reps. Have you returned one of these problematic catheters to the company for the engineers to take a look at it? What are they saying?
Finally have you searched the MAUDE database for similar occurrences with this same brand of catheter? You can do that here
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
And have you reported this problem to the FDA MedWatch system? You can do that here
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Lynn
Lynn Hadaway, M.Ed., RN, BC, CRNI
Lynn Hadaway Associates, Inc.
126 Main Street, PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861