BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2162723 · Received July 14, 2011

    Report

    Report Number
    6000001-2011-11958
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - TOONGABBIE
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE ACTUAL SAMPLE FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE BLUE CAP DISCONNECTED COMPLETELY FROM INJECTION SITE, THEREFORE THE CONDITION WAS CONFIRMED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. THE BLUE CONNECTOR USED ON THIS EVA BAG IS PURCHASED FROM AN EXTERNAL SUPPLIER. BASED ON A SIMILAR COMPLAINT RECEIVED, A SCAR (SUPPLIER CORRECTIVE ACTION REPORT) WAS ISSUED TO THE SUPPLIER. AFTER INVESTIGATIONS PERFORMED, THE SUPPLIER CONFIRMED THAT AS A CORRECTIVE ACTION, (B)(4).

    Description of Event or Problem · 1

    BAXTER PHARMACY SERVICES REPORTED THAT THE BLUE CAP ON THE ADDITIVE PORT OF THE 500ML PVC BAG, WHICH IS MEANT TO STAY IN PLACE AFTER SNAPPING OFF THE TOP, FAILS TO DO SO. WHEN YOU PUSH THE SPIKE THE WHOLE THING COMES OFF, DOES NOT BREAK - THE CLOSURE DOES NOT APPEAR TO BE AS TIGHT AS IT USED TO BE SO THE WHOLE THING CAN COME OFF. THIS CREATES A PROBLEM AS THE OPAQUE CAP CAN'T BE FASTENED SECURELY IN PLACE. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - TOONGABBIE 10I15V830M

    Patients

    Seq Age Sex Outcome Treatment
    1