BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTIV PLUS CATHETER

    MDR report key: 316516 · Received February 19, 2001

    Report

    Report Number
    MW1021112
    Event Type
    Malfunction
    Date Received
    February 19, 2001
    Date of Event
    February 9, 2001
    Report Date
    February 19, 2001
    Manufacturer
    J+J MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROTECTIVE IV CATHETER FAILED AND CAUSED NEEDLE STICK ON DISPOSAL. RN WAS STARTING PT'S INTRAVENOUS WITH #18 GAUGE 1 1/4" PROTECTIVE PLUS CATHETER - JOHNSON&JOHNSON. STATES WITHDREW INTRODUCER NEEDLE INTO NEEDLE GUARD AND HEARD "CLICK" TO ENGAGE SAFETY DEVICE. NEEDLE GUARD DID NOT COMPLETELY COVER INTRODUCER NEEDLE RESULTING IN A NEEDLESTICK INJURY WHILE DISPOSING OF THE UNIT. THE NEEDLESTICK INJURY REQUIRED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6388 PROTECTIV PLUS CATHETER NEEDLE PROTECTOR FOZ J+J MEDICAL 3065 2900 K 70

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other