BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO PROTECTIV

    MDR report key: 2312943 · Received October 26, 2011

    Report

    Report Number
    2312943
    Event Type
    Malfunction
    Date Received
    October 26, 2011
    Date of Event
    October 17, 2011
    Report Date
    October 26, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS FACILITY IS EXPERIENCING ISSUES WITH THE JELCO PROTECTIV PLUS CATHETERS.18G X 1 1/4"LOT ST 2077281 EXP. DATE 2014/07.THE EXPERIENCED EMERGENCY DEPARTMENT NURSE REPORTED THAT A #18 WAS INSERTED INTO THE PATIENT'S ARM WITHOUT DIFFICULTY PER PROTOCOL. WHEN THE NURSE TRIED TO ADVANCE THE CATHETER INTO THE VEIN AND OFF OF THE NEEDLE, THE CATHETER WOULD NOT MOVE. THE NURSE HAD TO USE OTHER HAND TO PRY THE CATHETER OFF THE NEEDLE AND ADVANCE IT AND EVENTUALLY THE NEEDLE ADVANCED. BLOOD FILLED MORE THAN JUST IN THE DRIP CHAMBER, IT STARTED FILLING UP THE AREA WHERE THE NEEDLE IS STORED AFTER INSERTION. TWO BAGS OF IV FLUID WERE INFUSED WITHOUT DIFFICULTY. THIS DEVICE WAS GIVEN TO THE SMITHS MEDICAL QUALITY CONTROL REPRESENTATIVE.LOT ST 1983801 EXP. DATE: 2014/07. AN EXPERIENCED ED EMERGENCY DEPARTMENT RN HAD DIFFICULTY ADVANCING THE CATHETER OFF OF THE NEEDLE. GIVEN TO SMITHS MEDICAL. AN INTERNAL RECALL WAS CONDUCTED AND LOT ST 1983801 WAS PULLED FROM STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO PROTECTIV PERIPHERAL L.V. CATHETERS FOZ SMITHS MEDICAL * ST1983801 AND ST2077281

    Patients

    Seq Age Sex Outcome Treatment
    1 *