BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS® PBS/EDTA BUFFER

    MDR report key: 5108562 · Received September 28, 2015

    Report

    Report Number
    3005290010-2015-00009
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    July 14, 2015
    Report Date
    September 17, 2015
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    UDI-DI
    04049934001666
    PMA / PMN Number
    BH110018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED BY MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY FOUND A SMALL, BLACK AND RUBBER-LIKE FRAGMENT IN ONE OF THEIR CLINIMACS PBS/EDTA BUFFER BAGS 1L, AFTER SPIKING. THE DEBRIS WAS IDENTIFIED PRIOR TO CELL PROCESSING AND THEREFORE THE PATIENTS CELL PROCESSING MATERIAL FOR TRANSPLANTATION WAS NOT AFFECTED. THE SITE HAD A SPARE BUFFER ON HAND THAT WAS USED FOR THE CELL SEPARATION PROCESS. THE CELL SAMPLE WAS ADMINISTERED TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, HARM TO THE PATIENT CAN BE EXCLUDED. THE EVENT HAPPENED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639425 CLINIMACS® PBS/EDTA BUFFER CLINIMACS® PBS/EDTA BUFFER OVG MILTENYI BIOTEC GMBH N/A D0525 04049934001666

    Patients

    Seq Age Sex Outcome Treatment
    1