BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELCAM THREE WAY STANDARD BORESTOPCOCK WITH

    MDR report key: 2022741 · Received March 17, 2011

    Report

    Report Number
    6000001-2011-01962
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K962581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED ISSUE WAS CONFIRMED VIA PHOTO EVALUATION. THE ACTUAL SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE THAT WHILE ASSESSING THE PATIENT, NURSE OBSERVED THE ELCAM 3-WAY STANDARD BORE STOPCOCK TO PATIENT'S UMBILICAL VENOUS CATHETER WAS CRACKED AND LEAKING BLOOD IN PATIENT'S BED. THE PATIENT WAS LYING IN BLOOD AND TOTAL PARENTERAL NUTRITION (TPN). THE PATIENT WAS STABLE AND THE STOPCOCK WAS SWITCHED OUT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELCAM THREE WAY STANDARD BORESTOPCOCK WITH STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 UMBILICAL VENOUS CATHETER