BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT STERILE SYRINGE

    MDR report key: 31735 · Received April 4, 1996

    Report

    Report Number
    MW4001142
    Event Type
    Malfunction
    Date Received
    April 4, 1996
    Report Date
    February 29, 1996
    Manufacturer
    SHERWOOD MEDICAL CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WHITE PARTICULATE MATTER ON ATTACHED 22GA 1 1/2" NEEDLE. THIS SYRINGE WAS OPEN. THE CAP WAS SEALED. UPON TAKING THE SYRINGE OUT OF THE CASING AND REMOVING THE NEEDLE COVER, DR NOTICED THE NEEDLE HAD SOME WHITE SPOTS ON IT. THE NEEDLE WAS CAPPED, THE SYRINGE AND NEEDLE PLACED BACK INTO THE CASING. DR WANTS A REPORT BACK AS TO WHY AND WHAT WAS THE WHITE SUBSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT STERILE SYRINGE STERILE SYRINGE, 12 ML FMF SHERWOOD MEDICAL CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO