BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1L PL2410 PLASTIC STORAGE CONTAINER - 1000 ML

    MDR report key: 1673837 · Received April 20, 2010

    Report

    Report Number
    3004548776-2010-00002
    Event Type
    Malfunction
    Date Received
    April 20, 2010
    Date of Event
    March 25, 2010
    Report Date
    March 25, 2010
    Manufacturer
    FENWAL, INC.
    Product Code
    KSR
    PMA / PMN Number
    BK990009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE UNUSED SAMPLES WERE RECEIVED FROM THE USER FACILITY. VISUAL INSPECTION NOTED EXCESS SEALING ON THE TUBING ASSEMBLED TO THE Y JUNCTION OF THE ANCILLARY STORAGE BAG. THE ROOT CAUSE HAS DETERMINED TO BE RELATED TO THE HEAT SEAL EQUIPMENT WHICH HAS BEEN REMOVED FROM SERVICE. A NEW HEAT SEALER HAS BEEN INSTALLED AND VALIDATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USER FACILITY INDICATING LEAKS AND/OR INADEQUATE SEALING ON THE ANCILLARY BAG. THE EVENTS WERE NOTED DURING STERILE DOCKING OF THE ANCILLARY PLATELET STORAGE BAG TO THE FINAL PRODUCT POST-DONATION; THEREFORE, THE DONOR WAS NOT AFFECTED. THERE HAVE BEEN NO REPORTS OF ADVERSE EVENT, RECIPIENT REACTION OR BACTERIAL CONTAMINATION DOCUMENTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1L PL2410 PLASTIC STORAGE CONTAINER - 1000 ML EMPTY CONTAINER FOR PLATELET STORAGE KSR FENWAL, INC. NA FA10A26035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA