BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL TRANSFER/FREEZING BAG SET

    MDR report key: 1896966 · Received November 11, 2010

    Report

    Report Number
    9617787-2010-00013
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ENSATEC, S.A. DE C.V.
    Product Code
    KSR
    PMA / PMN Number
    BK980027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS NOT AN "ADVERSE EVENT", BUT RATHER A "PRODUCT PROBLEM".UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 TEST UNITS OF FROZEN CORD BLOOD PRODUCT WERE BEING THAWED AS PART OF A PROCESS VALIDATION. THE STORAGE BAGS OF TWO OF THE SIX UNITS, FROM DIFFERENT MANUFACTURING LOTS, WERE OBSERVED TO BREAK STARTING FROM THE SEAL AREA BETWEEN BAG BRIDGES ALL THE WAY TO THE BAG SURFACE. THE CUSTOMER DID NOT SUPPLY PALL WITH THE ACTUAL LOT NUMBERS, ONLY THE BATCH LOT NUMBERS. BASED ON THE SHIPMENT HISTORY, PALL FEELS THAT THE POSSIBLE LOT NUMBERS ARE: LOT #1053017 WAS MANUFACTURED ON FEBRUARY 8, 2010 AND HAS AN EXPIRATION DATE OF FEBRUARY 8, 2013. (B)(4). LOT #1053069 WAS MANUFACTURED ON MAY 26, 2010 AND HAS AN EXPIRATION DATE OF MAY 26, 2013. (B)(4). LOT #1053070 WAS MANUFACTURED ON MAY 28, 2010 WITH AN EXPIRATION DATED OF MAY 28, 2013. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL TRANSFER/FREEZING BAG SET TRANSFER/FREEZING BAG SET KSR ENSATEC, S.A. DE C.V. 791-02 1053017, 1053069

    Patients

    Seq Age Sex Outcome Treatment
    1