BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS PBS/EDTA BUFFER

    MDR report key: 5367475 · Received January 14, 2016

    Report

    Report Number
    3005290010-2016-00035
    Event Type
    Malfunction
    Date Received
    January 14, 2016
    Date of Event
    November 16, 2015
    Report Date
    January 8, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    PMA / PMN Number
    BH110018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONE OF THEIR CLINIMACS PBS/EDTA BUFFER BAG WAS PERFORATED ON RECEIPT BUT THE OVERPOUCH WAS STILL INTACT. THIS EVENT OCCURRED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25142 CLINIMACS PBS/EDTA BUFFER CLINIMACS PBS/EDTA BUFFER OVG MILTENYI BIOTEC GMBH D0539

    Patients

    Seq Age Sex Outcome Treatment
    1