BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-TYPE BLOOD/SOLUTION INFUSIONSET, COLLEAGUE AND FLOGARD

    MDR report key: 1891356 · Received November 4, 2010

    Report

    Report Number
    6000001-2010-04721
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE ACTUAL SAMPLE FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND THE REPORTED CONDITION WAS CONFIRMED. A SEPARATION WAS OBSERVED BETWEEN THE TUBING AND THE CLEARLINK ANNEALED Y-SITE. HOWEVER, AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAS NOT RETURNED THE SAMPLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, 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) OF A Y-TYPE BLOOD/SOLUTION INFUSION SET IN WHICH A LINE CAME COMPLETELY OFF DURING SET-UP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THE LOT NUMBER REPORTED, (B)(4), WAS NOT VALID. THIS IS REPORT 1 OF 2 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Y-TYPE BLOOD/SOLUTION INFUSIONSET, COLLEAGUE AND FLOGARD SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1