BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL TRANSFER/FREEZING BAG SET FOR PROCESSING AND FREEZING CORD BLOOD

    MDR report key: 1563650 · Received December 23, 2009

    Report

    Report Number
    9617787-2009-00040
    Event Type
    Malfunction
    Date Received
    December 23, 2009
    Date of Event
    November 24, 2009
    Report Date
    November 24, 2009
    Manufacturer
    ENSATEC, S.A. DE C.V.
    Product Code
    KSR
    PMA / PMN Number
    BK980027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    L/N 0853061 - MANUFACTURED 4/10/2008, EXPIRES 04/10/2011.L/N 0853068 - MANUFACTURED 4/17/2008, EXPIRES 04/17/2011.

    Additional Manufacturer Narrative · 1

    UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A (B) (6) PROCESSING CENTER THAT IT WAS NOT POSSIBLE TO PROCEED PAST THE STANDARD PROCEDURE AT THE STAGE WHEN DMSO IS ADDED TO THE FREEZER BAG BECAUSE OF AN APPARENT BLOCKAGE. AN ALTERNATE ROUTE WAS USED TO ADD DMSO TO THE SET.

    Description of Event or Problem · 1

    NEEDLE ON ENDO STITCH KEPT FALLING OFF. CHANGED PRODUCTS. HAD NO OTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL TRANSFER/FREEZING BAG SET FOR PROCESSING AND FREEZING CORD BLOOD TRANSFER/FREEZING BAG SET KSR ENSATEC, S.A. DE C.V. 791-02T 0853061 & 0853068

    Patients

    Seq Age Sex Outcome Treatment
    1