BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIN SET. FOR LBL. BLD. DERIVW LL

    MDR report key: 1970875 · Received January 26, 2011

    Report

    Report Number
    6000001-2011-00447
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 7, 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): CORRECTION/ADDITIONAL INFORMATION. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(6) A BLOOD DRIP CHAMBER SET WITH 200 MICRON FILTER AND BALL VALVE THAT "A PIECE HAS BROKEN OFF AND SAT WITHIN THE CHAMBER AND TUBE IS PROTRUDING MORE INTO THE CHAMBER THAT HAS THE BALL." THE CONDITION WAS IDENTIFIED DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT. THEREFORE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY. NO ADDITIONAL INFORMATION IS 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 10G31V138

    Patients

    Seq Age Sex Outcome Treatment
    1