BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTIV I.V. CATHETER SAFETY SYSTEM

    MDR report key: 117987 · Received September 5, 1997

    Report

    Report Number
    1618732-1997-00251
    Event Type
    Malfunction
    Date Received
    September 5, 1997
    Date of Event
    August 1, 1997
    Report Date
    August 7, 1997
    Manufacturer
    JOHNSON & JOHNSON MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AS THE CATHETER WAS BEING THREADED INTO THE VEIN, THE PUSHTAB STOPPED AND COULD NOT BE ADVANCED ANY FURTHER. THE NURSE ADVANCED THE REST OF THE CATHETER BY THREADING OFF OF THE NEEDLE WITH THEIR FINGER ON THE CATHETER HUB. THE DEVICE DID NOT LOCK AFTER IT WAS REMOVED AND THE NEEDLE WAS LEFT EXPOSED. THERE WAS NO NEEDLESTICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTIV I.V. CATHETER SAFETY SYSTEM IV CATHETER FOZ JOHNSON & JOHNSON MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN