BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TM6000 END PRODUCT TESTER SYRINGE

    MDR report key: 7628841 · Received June 21, 2018

    Report

    Report Number
    MW5077989
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    June 20, 2018
    Report Date
    June 20, 2018
    Manufacturer
    QI MEDICAL, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TECH NOTICED A TM6000 END PRODUCT TESTER SYRINGE (LOT# 1806102, EXP 03/01/2020) CONTAMINATED WITH BLACKISH FUZZY CLUSTER NEAR BLACK PORTION OF PLUNGER AND MEDIUM IS DARKER IN COLOR THAN USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468574 TM6000 END PRODUCT TESTER SYRINGE TM6000 END PRODUCT TESTER PUMP / SYRINGE, PISTON FMF QI MEDICAL, INC. 1806102TSB

    Patients

    Seq Age Sex Outcome Treatment
    1