BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIRO MEDICAL

    MDR report key: 928479 · Received October 15, 2007

    Report

    Report Number
    MW5004091
    Event Type
    Malfunction
    Date Received
    October 15, 2007
    Date of Event
    October 4, 2007
    Report Date
    October 15, 2007
    Manufacturer
    INVIRO MEDICAL DEVICES INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEEDLES TO INSULIN SYRINGES BEND TOO EASY. 60CC SYRINGE DOES NOT ADMINISTER CORRECT DOSAGE OF MEDICATION WHEN A PUMP IS USED. SYRINGES LEAK AROUND THE SHIELD. SYRINGE (3CC) DOES NOT FIT IN NUCLEAR MED SYRINGE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIRO MEDICAL INVIRO SNAP 3CC NEEDLE FMF INVIRO MEDICAL DEVICES INC. 3CC 063949
    2 INVIRO MEDICAL INVIRO SNAP 60CC NEEDLE FMF INVIRO MEDICAL DEVICES INC. 60CC 063949

    Patients

    Seq Age Sex Outcome Treatment
    1 YR