BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL TRANSFER/FREEZING BAG SET

    MDR report key: 1022505 · Received April 3, 2008

    Report

    Report Number
    9617787-2008-00009
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 21, 2007
    Report Date
    March 11, 2008
    Manufacturer
    ENTASEC S.A. DE C.V.
    Product Code
    KSR
    PMA / PMN Number
    BK980027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS EVALUATED IN THE FIRM'S ENGINEERING DEPARTMENT. WE CONFIRMED THE PRESENCE OF A LEAK AT THE CONNECTOR BETWEEN THE SPIKE AND THE 200 ML TRANSFER BAG COMPONENTS OF THE DEVICE. EXAMINATION SHOWED A CLEAR INTERFACE AROUND THE PERIMETER OF THE CONNECTOR WHERE THE TUBING IS INSERTED. THIS CONFIRMS THAT THE SOLVENT MADE A COMPLETE BOND AT THIS JOINT. HOWEVER, IN THE REGION OF THE TUBING JUST BEYOND THE INTERFACE, WHERE THE TUBING EMERGES FROM THE CONNECTOR, A BREAK WAS OBSERVED IN THE TUBING. THIS BREAK APPEARS TO VIRTUALLY SEVER THE TUBING ALMOST 50% AROUND THE PERIMETER. PROXIMATE CAUSE: NORMALLY, THE SOLVENT SOFTENS THE TUBING A BIT, BUT THEN EVAPORATES LEAVING THE TUBING AS STRONG AS IT WAS ORIGINALLY. IN THIS CASE, IT APPEARS THAT THE TUBING MAY HAVE TAKEN AN UNNATURAL CURVE DURING PACKAGING. THIS CURVE PUTS TENSION ON THE TUBING, BENDING IT AWAY FROM THE CONNECTOR. SOFTENED BY THE SOLVENT, THE TUBING THEN TORE ALONG A SIGNIFICANT PORTION OF ITS PERIMETER. AFTER THE SOLVENT EVAPORATED, THE TORN TUBING REMAINED. ROOT CAUSE: FURTHER EVALUATION OF THE PACKAGING PROCESS IS PLANNED TO ATTEMPT TO IDENTIFY A SPECIFIC ROOT CAUSE. SUMMARY: THE REPORTER'S OBSERVATION OF LEAKAGE WAS CONFIRMED. THE CAUSE OF THE LEAK APPEARS TO BE RELATED TO LATERAL FORCE ON THE TUBING DURING THE SOLVENT-BONDING STEP OF MANUFACTURING. THE ROOT CAUSE IS TO BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A CORD BLOOD PROCESSING FACILITY THAT A UNIT OF CORD BLOOD WAS TRANSFERRED INTO THE DEVICE, A TRANSFER/FREEZER BAG SET AND PROCESSED SUCCESSFULLY UNTIL THE STAGE WHEN THE CORD BLOOD WAS PLACED ON THE PLASMA EXTRACTOR. IT WAS NOTED THAT THE PLASMA WAS LEAKING FROM THE JOINT OR JUNCTION OF THE PORT NEAREST THE COLLECTION BAG. THE UNIT WAS TRANSFERRED TO ANOTHER UNIT AND FURTHER PROCESSED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL TRANSFER/FREEZING BAG SET TRANSFER/FREEZING BAG SET KSR ENTASEC S.A. DE C.V. 791-02 0753091

    Patients

    Seq Age Sex Outcome Treatment
    1