BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROMED

    MDR report key: 61698 · Received January 13, 1997

    Report

    Report Number
    MW4001744
    Event Type
    Malfunction
    Date Received
    January 13, 1997
    Date of Event
    October 11, 1996
    Report Date
    October 14, 1996
    Manufacturer
    Q.I. MEDICAL
    Product Code
    JTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    MEDIA USED IN QA TESTING (END PRODUCT STERILITY TESTING OF IV'S) WAS UNOPENED AND NOTICED TO BE TURBID. TAKEN TO LAB AND PLATED OUT. WAS CONTAMINATED WITH GRAM AND BACILLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROMED TSB MEDIA FOR STERILITY TESTING JTO Q.I. MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *