BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESOURCE CUSTOM PICC LINE PLACEMENT KIT

    MDR report key: 1003685 · Received January 28, 2008

    Report

    Report Number
    1003685
    Event Type
    Malfunction
    Date Received
    January 28, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 28, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    OUR PICC TEAM HAS HAD AN ONGOING ISSUE WITH THE SCISSORS CONTAINED WITHIN THE CARDINAL HEALTH PICC KITS. THESE WERE EARLIER REPORTED AS BELONGING TO A DIFFERENT MANUFACTURER (1 PAIR) HOWEVER ON FURTHER RESEARCH WE HAVE CONFIRMED THESE SCISSORS ARE MANUFACTURED BY SURGICAL DESIGN INSTRUMENTS. OUR PICC NURSES HAVE REPORTED THESE SCISSORS WILL NOT CUT THE PICC LINE IN THE KIT THESE ARE PART OF. THE NURSES HAVE HAD TO RESORT TO USING A SCALPEL WHICH IS ALSO INCLUDED IN THE KIT. PICC LINES NEED TO HAVE A PRECISE CLEAN EDGE,THESE SCISSORS HAVE BEEN GNASHING THE LINE. THESE ARE PART OF A PICC LINE PLACEMENT KIT WE PURCHASE THROUGH CARDINAL HEALTH. OUR REP HAS ARRANGED FOR THESE SCISSORS TO BE SWITCHED OUT TO A DIFFERENT SCISSOR. I DO HAVE 3 PAIRS FOR EVALUATION PURPOSES.====================== MANUFACTURER RESPONSE FOR 4 1/2" SATIN FINISH SCISSOR, SURGICAL DESIGN INSTRUMENTS======================MANUFACTURER WILL BE MADE AWARE BY THIS MEDWATCH. WE PURCHASE THESE THROUGH CARDINAL HEALTH IN PRESOURCE KITS PACKAGED FOR US. CARDINAL HEALTH HAS ARRANGED FOR DIFFERENT SCISSORS TO BE CONTAINED IN OUR KITS IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESOURCE CUSTOM PICC LINE PLACEMENT KIT KIT, PICC PLACEMENT LJS CARDINAL HEALTH 81450SG *
    2 4 1/2 " SATIN FINISH SCISSORS SCISSORS, DISPOSABLE LRW SURGICAL DESIGN INSTRUMENTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *