BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL PURECELL RCQ

    MDR report key: 617296 · Received June 20, 2005

    Report

    Report Number
    617296
    Event Type
    Malfunction
    Date Received
    June 20, 2005
    Date of Event
    June 2, 2005
    Report Date
    June 20, 2005
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THREE PALL PURECELL RCQ BLOOD FILTERS WERE FOUND TO LEAK ABOVE THE B CLAMP THROUGH THE AIR VENT. ANOTHER FILTER FROM A DIFFERENT LOT NUMBER WAS USED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL PURECELL RCQ LEUKOCYTE REDUCTION FILTER CAK PALL BIOMEDICAL PRODUCTS CO. 141RCQT0 0550002

    Patients

    Seq Age Sex Outcome Treatment
    1 *