BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL TRANSFER/FREEZING BAG SET

    MDR report key: 827183 · Received November 1, 2006

    Report

    Report Number
    2013342-2006-00005
    Event Type
    Malfunction
    Date Received
    November 1, 2006
    Date of Event
    September 28, 2006
    Report Date
    October 5, 2006
    Manufacturer
    PALL MEDSEP
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION STARTED, BUT NOT YET COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE FIRM ON OCTOBER 5, 2006, BY THE COMPANY, THAT IN TURN HAD BEEN INFORMED BY THE TRANSPLANT CENTER IN ANOTHER COUNTRY, (TO WHICH THE COMPANY HAD SHIPPED THE CORD BLOOD UNIT) THAT A SEAM ON A CORD BLOOD FREEZING BAG DEVELOPED MICRO-LEAKS, WHICH WERE NOT DETECTED IN THE FOREIGN CENTER'S RECEIVING INSPECTION, IN THE WELDING OF THE FREEZING BAG. THE FOREIGN CENTER DETECTED THIS LEAK DURING ITS THAWING OF THE CORD BLOOD GRAFT. THE CORD BLOOD UNIT HAD ORIGINALLY BEEN PROCESSED AND FROZEN IN 2002, USING THE FIRM'S DEVICE BEARING PROCESSING SET LOT#0200802, EXP. 08/2005. THE FREEZING BAG HAD AN ADD'L PRINTED LOT#0010. FOLLOWING THE BREACH IN THE INTEGRITY OF THE FREEZING BAG. THE CELLS WERE SALVAGED AND TRANSPLANTED INTO THE PT. THE RECIPIENT WAS REPORTED TO BE WELL AS 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL TRANSFER/FREEZING BAG SET KSR:EMPTY CONTAINERS FOR THE COLLECTION, MANUAL PROCESSING, KSR PALL MEDSEP 791-02 0200802

    Patients

    Seq Age Sex Outcome Treatment
    1 *