BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEAR CHOICE DCB

    MDR report key: 387337 · Received April 5, 2002

    Report

    Report Number
    MW1024635
    Event Type
    Other
    Date Received
    April 5, 2002
    Date of Event
    January 17, 2002
    Report Date
    January 25, 2002
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    KPE
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DURING FILLING OF LOWER CHAMBER OF TWO BAGS, IT WAS NOTED THAT THERE WAS A PINHOLE LEAK SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR CHOICE DCB EMPTY DUAL CHAMBER BAG KPE B. BRAUN MEDICAL INC * 1/03121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other