BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIN SET. FOR LBL. BLD. DERIVW LL

    MDR report key: 1982517 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00762
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE ACTUAL SAMPLE FOR EVALUATION. THROUGH VISUAL INSPECTION THE REPORTED CONDITION WAS CONFIRMED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. THE CONDITION WAS DETERMINED TO BE DUE TO THE PACKING PROCESS. SEVERAL ACTIONS HAVE BEEN PUT IN PLACE TO PREVENT THIS CONDITION FROM RECURRING; HOWEVER, FURTHER INVESTIGATIONS ARE CURRENTLY ONGOING TO EVALUATE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) REGARDING A BLOOD ADMINISTRATION SET IN WHICH THE TUBING HAS A LARGE SPLIT ON IT AND WAS OBSERVED ON (B)(6) 2011. THERE WAS NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADMIN SET. FOR LBL. BLD. DERIVW LL SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - MALTA 10I30V796

    Patients

    Seq Age Sex Outcome Treatment
    1