BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    250 ML MEDIBAG

    MDR report key: 1965178 · Received December 30, 2010

    Report

    Report Number
    1722214-2010-00013
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 14, 2010
    Manufacturer
    SUMMIT MEDICAL PRODUCTS, INC
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF THE MEDIBAG HAVING A LEAK WAS CONFIRMED. THE BAGS LEAKS WHERE THE BUSHING MEETS THE INNER OF THE BAG WAS CONFIRMED. CORRECTIVE ACTION 1479 WAS OPENED TO ADDRESS THE ISSUE. (NOTE: EVEN THOUGH CAR 1479 DOES NOT SPECIFICALLY REFERENCE LN D004316, IT IS THE SAME FAILURE EXPERIENCED WITH A PREVIOUS LOT). IN THE FINAL REPORT FROM THE CORRECTIVE ACTION, IT WAS NOTED THAT THE 100% VISUAL INSPECTION OF THE MEDIBAGS FROM MANUFACTURING DID NOT OCCUR, THUS CAUSING FAILURES TO BE PASSED ON THE NEXT STAGE. IT WAS ALSO NOTED THAT THE COOLING SYSTEM ON THE MOLD MACHINE WAS NOT COOLING APPROPRIATELY. THE HOLE OR GAP ON THE MEDIBAG WAS CAUSED BECAUSE THE MATERIAL WAS STILL HOT WHEN THE BAGS WERE FORMED AND REMOVED FROM THE MOLD MACHINE. SINCE THE CORRECTIVE ACTION WAS GENERATED, TRAINING HAS BEEN PERFORMED BY THE CONTRACT MANUFACTURE. ALSO VISUAL AIDS HAVE BEEN PUT ON THE MANUFACTURING FLOOR OF WHAT IS NOT ACCEPTABLE. MANUFACTURING IS ADDING A COOLING SYSTEM FOR THE MOLD MACHINE TO PREVENT THE MATERIAL FROM GAPPING DURING THE REMOVAL OF THE BAG. AN INCREASE IN SAMPLING WILL OCCUR FOR THE NEXT THREE LOTS TO PROVE EFFECTIVENESS. THIS LOT WAS PRODUCED PRIOR TO THE CORRECTIVE ACTION BEING ISSUED.

    Description of Event or Problem · 1

    TWO UNITS OF 250 ML MEDIBAGS WERE FOUND TO BE LEAKING WHERE THE BUSHING MEETS THE INNER PART OF THE BAG. THE BAGS WERE NOT USED ON PATIENTS. THE LEAKS WERE NOTICED DURING SALINE MEDICATION FILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 250 ML MEDIBAG 250 ML MEDIBAG KPE SUMMIT MEDICAL PRODUCTS, INC 220121 D004316

    Patients

    Seq Age Sex Outcome Treatment
    1