BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT SYRINGE

    MDR report key: 33414 · Received June 13, 1996

    Report

    Report Number
    MW1009295
    Event Type
    Malfunction
    Date Received
    June 13, 1996
    Date of Event
    June 1, 1996
    Report Date
    June 6, 1996
    Manufacturer
    SHERWOOD MEDICAL CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    FINALLY, A REVIEW OF THE COMPLAINT DATABASE DID NOT UNCOVER ANY SIMILAR COMPLAINTS LOGGED AGAINST THE TWO LOTS IN QUESTION. CO'S FINDINGS, BOTH VISUAL AND FUNCTIONAL, SUGGESTS THAT UNDER NORMAL CONDITION OF USAGE THE PRODUCT SHOULD HAVE PERFORMED SATISFACTORILY WITH NO LEAKAGE. THIS IS CORROBORATED BY A LACK OF SIMILAR COMPLAINTS ON THE LOTS CITED IN THIS COMPLAINT. FINALLY WITH REGARD TO THE LEAKAGE, CO WOULD ADVISE THAT IT IS POSSIBLE FOR SYRINGES TO LEAK AT THE PLUNGER IF A SIDEWAYS FORCE IS APPLIED DURING COMPRESSION OF THE FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT SYRINGE SYRINGE FMF SHERWOOD MEDICAL CO. 240442, 240443

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO