BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT-MPAK-FL-SYR-HF-200MLBX50

    MDR report key: 3915249 · Received May 27, 2014

    Report

    Report Number
    9610849-2014-00004
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 2, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K031339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MALLINCKRODT APAC CUSTOMER REPORTS WHEN STAFF OPENED THE SYRINGE PACKAGE, THEY NOTED DUST FOUND INSIDE THE 200 ML EMPTY SYRINGE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311291 CT-MPAK-FL-SYR-HF-200MLBX50 DXT LIEBEL FLARSHEIM CT-MPAK-FL-SYR-HF 132700166X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA