BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENWAL TRANSFER PACK CONTAINER 300ML

    MDR report key: 12217212 · Received July 22, 2021

    Report

    Report Number
    MW5102731
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    July 20, 2021
    Report Date
    July 20, 2021
    Manufacturer
    FENWAL, INC.
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    HPC, APHERESIS PRODUCT WAS LOST DUE A CRACK IN THE 300 ML TRANSFER BAG. AFTER SAMPLING, CLS CONNECTED THE COLLECTION BAG TO 300 ML TRANSFER BAG. SUBSEQUENTLY HE NOTICED THAT THE WHOLE PRODUCT WAS LEAKED OUT OF THE BAG. WE EXAMINED THE BAG AND UNFORTUNATELY THE 300 ML TRANSFER BAG HAD A CRACK. FENWAL TRANSFER PACK CONTAINER WITH COUPLER 300ML. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112654 FENWAL TRANSFER PACK CONTAINER 300ML CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS KSR FENWAL, INC. 4R2014 FA19I26146

    Patients

    Seq Age Sex Outcome Treatment
    1 Other