BEUDAMED
    FDA Adverse Event Summary report: N

    HEX HANDLE SUMP SUCKER

    MDR report key: 42142 · Received October 9, 1996

    Report

    Report Number
    MW4001633
    Date Received
    October 9, 1996
    Report Date
    July 29, 1996
    Manufacturer
    TEXAS MEDICAL PRODUCTS, INC.
    Product Code
    DTS
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TINY HOLES WERE NOTED IN THE PACKAGING INTEGRITY OF STERILE DISPOSABLE SURGICAL SUCKERS AND ADULT SUMP SUCKERS. THE PACKAGING HOLES WERE DETECTED USING AN ARTIFICIAL LIGHT SOURCE AND PASSING OF WATER THROUGH THE PACKAGE. THE ITEMS WERE INSPECTED UPON ARRIVAL IN THE FACILITY AND THEREFORE THERE IS NO QUESTION OF COMPROMISE TO THE PACKAGING AFTER RECEIPT. THE CO WAS IMMEDIATELY NOTIFIED. NO ITEM WITH QUESTIONABLE PACKAGING INTEGRITY WAS PLACED INTO CIRCULATION AFTER THE PROBLEM WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEX HANDLE SUMP SUCKER SURGICAL SUCKER DTS TEXAS MEDICAL PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *