BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULB IRRIGATION SYRINGE, 60 CC

    MDR report key: 29250 · Received January 4, 1996

    Report

    Report Number
    MW1008059
    Event Type
    Malfunction
    Date Received
    January 4, 1996
    Date of Event
    December 28, 1995
    Report Date
    December 29, 1995
    Manufacturer
    PROFESSIONAL MEDICAL PRODUCTS, INC.
    Product Code
    KYZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE FINGER GRIP TABS AREA TEARING THROUGH THE STERILE PACKAGE OF 60 CC BULB IRRIGATION SYRINGES. THIS HAS HAPPENED SEVERAL TIMES IN THE PAST FEW WEEKS. RPTR ALSO HAD ONE WITH A TEAR IN THE PACKAGE AT THE TIP OF THE BULB SYRINGE. THIS IS A DISPOSABLE ITEM SO THE CONTENTS ARE CONTAMINATED AND UNUSABLE. RPTR HAS NOT EXPERIENCED THIS PROBLEM WITH PREVIOUS BRANDS OR WITH THIS BRAND UNTIL RECENTLY. TORN PACKAGES WITH CONTENTS AND A COPY OF THIS REPORT WILL BE GIVEN TO THE LOCAL DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BULB IRRIGATION SYRINGE, 60 CC IRRIGATION SYRINGE KYZ PROFESSIONAL MEDICAL PRODUCTS, INC. 512743 X 2 AND 511119

    Patients

    Seq Age Sex Outcome Treatment
    1 *