BEUDAMED
    FDA Adverse Event Other Summary report: N

    KLEEN-NEEDLE SYSTEM 5" EXTENSION SET WITH HEPARIN LOCK

    MDR report key: 13727 · Received June 2, 1994

    Report

    Report Number
    MW1002324
    Event Type
    Other
    Date Received
    June 2, 1994
    Date of Event
    February 1, 1994
    Report Date
    April 28, 1994
    Manufacturer
    TRI-STATE HOSPITAL SUPPLY CORP.
    Product Code
    FOZ
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON FOUR OCCASIONS FROM 2/94 UNTIL PRESENT, RPTR FOUND THE DEVICE TO HAVE HAD CAP MISSING FROM SET WHILE IN USE ON PTS. THE CAP IS LUER-LOCKED ONTO TUBING. THE PTS INVOLVED WERE NOT RESTLESS OR KNOWN TO BE MANIPULATING EQUIPMENT. RPTR SUSPECTS THAT THROUGH USE, WITH ACCESSING BY ACCOMPANYING RECESSED NEEDLE, THAT AS DEVICE IS ACCESSED AND DEACCESSED THE CAP IS BEING LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLEEN-NEEDLE SYSTEM 5" EXTENSION SET WITH HEPARIN LOCK FOZ TRI-STATE HOSPITAL SUPPLY CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other