BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULB IRRIGATION SYRINGE, 60CC

    MDR report key: 30737 · Received March 4, 1996

    Report

    Report Number
    MW1008499
    Event Type
    Malfunction
    Date Received
    March 4, 1996
    Report Date
    March 1, 1996
    Manufacturer
    PROFESSIONAL MEDICAL PRODUCTS, INC.
    Product Code
    KYZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC WINGS OF THE SYRINGE SOMETHIMES ROTATE AND TEAR HOLES IN THE PAPER BACKING OF THE PACKAGE RENDERING THE PRODUCT NONSTERILE AND PRESENTING A RISK OF INFECTION IF NOT DISCOVERED BEFORE THE PRODUCT IS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BULB IRRIGATION SYRINGE, 60CC BULB IRRIGATION SYRINGE KYZ PROFESSIONAL MEDICAL PRODUCTS, INC. 513867

    Patients

    Seq Age Sex Outcome Treatment
    1 *