BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL CATHETER EXT SET/LUER ACT.VALVE MLL ADAPTER

    MDR report key: 1941536 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06377
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 5, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE DEVICE HAS BEEN MADE. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER I.V. THERAPY REPRESENTATIVE A CLEARLINK CATHETER EXTENSION SET IN WHICH THE PROXIMAL END OF THE SET BECAME DETACHED FROM THE TUBING AND CAUSED THE PATIENT TO BLEED SLIGHTLY. THE INCIDENT OCCURRED IN THE ICU. NO ADVERSE EVENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL CATHETER EXT SET/LUER ACT.VALVE MLL ADAPTER SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PRIMARY SET