BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT SYRINGE WITH PLASTIC LUER LOCK TIP

    MDR report key: 32742 · Received May 7, 1996

    Report

    Report Number
    MW1009037
    Event Type
    Malfunction
    Date Received
    May 7, 1996
    Date of Event
    May 1, 1996
    Report Date
    May 6, 1996
    Manufacturer
    SHERWOOD MEDICAL CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    LOCK SYRINGES WITH PLASTIC LUER LOCK TIP STICK AT 5CC MARK SOMETIMES EVIDENT WITH SOME SYRINGES, THIS IS EVIDENT WHEN EMPTY, OTHER SYRINGES NOT EVIDENT. UNTIL SYRINGE IS FILLED AND AIR IS EXPELLED. WHEN THESE SYRINGES ARE USED WITH A SYRINGE PUMP, THE INFUSION WILL STOP AND ALARM AT THE 5CC MARK AND INFUSION CANNOT BE CONTINUED DUE TO PRESSURE IN SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT SYRINGE WITH PLASTIC LUER LOCK TIP SYRINGE, 20CC FMF SHERWOOD MEDICAL CO. 727010, 727008

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO