BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    36" HIGH FLOW RATE EXT SET

    MDR report key: 1982442 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00761
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE USED SAMPLE AND ONE USED B. BRAUN ULTRASITE IV SET CODE (B)(4), LOT UNKNOWN. THE (B)(4) EXTENSION SET SAMPLE ARRIVED OUT OF THE POUCH PRIMED. THE B. BRAUN SET WAS ALSO FULLY PRIMED. VISUAL INSPECTION OF THE (B)(4) EXTENSION SET MALE LUER CONFIRMED THAT IT WAS BROKEN OFF. CLOSER VISUAL INSPECTION UNDER A MICROSCOPE SHOWED THAT THERE ARE WHAT APPEAR TO BE STRESS MARKS AT THE BREAK POINT OF THE MALE LUER. THE LUER COLLAR WAS ALSO VISUALLY INSPECTED WHICH SHOWED A FRACTURE THROUGH ONE SIDE. THE B. BRAUN ULTRASITE LAD HAS WHAT APPEARS TO BE THE BROKEN PORTION OF THE (B)(4) MALE LUER EMBEDDED IN IT. IT APPEARS THAT THE (B)(4) MALE LUER BROKE DUE TO EXCESSIVE TORQUE/STRESS. THE COMPLAINT WILL BE CONFIRMED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER OF A HIGH FLOW RATE EXTENSION SET IN WHICH THE MALE END OF THE SYRINGE TUBING SNAPPED OFF IN THE MAIN LINE TUBING. THIS REPORTED CONDITION OCCURRED DURING PATIENT-USE WHILE ADMINISTERING IV MEDICATIONS ON (B)(6) 2010. A BD ULTRASITE IV SET FOR IV OUT LOOK SAFETY INFUSION SYSTEM, PRODUCT CODE US3140, WAS ALSO USED WITH THIS SET. THERE WAS NO REPORT OF ANY MEDICAL INTERVENTION OR PATIENT INJURY INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 36" HIGH FLOW RATE EXT SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR10J15022

    Patients

    Seq Age Sex Outcome Treatment
    1 ULTRASITE IV SET - IV OUTLOOK SAFETYINFUSIONSYSTEM