BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD REPAIR KIT

    MDR report key: 451343 · Received March 28, 2003

    Report

    Report Number
    MW1028002
    Event Type
    Malfunction
    Date Received
    March 28, 2003
    Date of Event
    February 21, 2003
    Report Date
    March 21, 2003
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD REPAIR KIT REPAIR KIT - HICKMAN CATHETER DQC BARD ACCESS SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other