BARD REPAIR KIT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-28 for BARD REPAIR KIT * manufactured by Bard Access Systems.

Event Text Entries

[265171] An immunocompromised pt's hickman catheter had a hole in leg and needed to be repaired. The reporter obtained a repair kit. The splice sleeve of the bard hickman catheter repair kit was in an unusual position on the replacement segment, i. E. , down over the end of the replacement segment and stent. The splice sleeve could not be moved and so it was impossible to accomplish the catheter repair. The reporter obtained a second kit from their hosp supply room, but the same problem was noted. In fact, all of the repair kits that they had on hand were defective. The reporter contacted bard customer service immediately in an attempt to get a usable repair kit. The reporter was told that all of the reps were at a conference and unavailable until the following week. The customer service rep connected them with a clinical rep. She asked many questions, but did not seem to be experienced in the use of the repair kit and was mainly interested in encouraging them to file a report with the co. She was of no assistance in helping them to get a usable product quickly. Their hospital purchasing dept. Placed an order, but the product that arrived in february 2003 was also defective. At that point they had to use a courier to get a repair kit from another hosp. The splice sleeve was observed to be in the correct position so they opened the kit. However, once again the sleeve would not move. It required 2 nurses, several minutes and lots of effort to finally dislodge the sleeve. They were finally able to accomplish the repair. The reporter began trying to reach the bard rep once again in february 2003. He eventually picked up the defective repair kits. In march 2003, the rep called to advise them that bard was acknowledging defects in the repair kits. To date the reporter does not know what is being done to correct this manufacturing problem.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1028002
MDR Report Key451343
Date Received2003-03-28
Date of Report2003-03-21
Date of Event2003-02-21
Date Added to Maude2003-04-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBARD REPAIR KIT
Generic NameREPAIR KIT - HICKMAN CATHETER
Product CodeDQC
Date Received2003-03-28
Returned To Mfg2003-03-04
Model Number*
Catalog Number*
Lot Number*
ID NumberREPORT FILE #5503020204
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key440342
ManufacturerBARD ACCESS SYSTEMS
Manufacturer Address5425 WEST AMELIA EARHART DR SALT LAKE CITY UT 84116 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-03-28

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