BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET W/LL T-CONNECTOR

    MDR report key: 390039 · Received April 19, 2002

    Report

    Report Number
    9610175-2002-00006
    Event Type
    Malfunction
    Date Received
    April 19, 2002
    Date of Event
    March 1, 2002
    Report Date
    March 22, 2002
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM ABBOTT INTERNATIONAL AFFILIATE (ABBOTT UNITED KINGDOM) WHICHS STATES. "RUBBER BUNG DISCONNECTED AND WAS LOST. NO BLOOD LOSS OCCURRED, AND NO PATIENT ILL-EFFECTS WERE NOTED." ADDITIONAL INFORMATION RECEIVED STATES, "THE HOSPITAL DECLINED TO RELEASE ANY PATIENT INFORMATION, A) TO MAINTAIN PATIENT CONFIDENTIALITY, AND B) BECAUSE THEY FELT THAT IT WAS NOT PERTINENT TO THE INVESTIGATION. THEY DID, HOWEVER, SUPPLY THE INFORMATION THAT THE PATEINT'S LIMB WAS IMMOBILIZED BY A SPLINT, THUS MAKING IT IMPOSSIBLE FOR THE PATIENT TO HAVE REMOVED THE BUNG. THE CO'S INFORMATION INDICATES THAT THE SET WAS NOT BEING ACCESSED AT THE TIME OF THE DISCONNECTION, WHICH WAS NOT ACTUALLY WITNESSED. APPARENTLY THE SET WAS IN USE TO CONNECT TPN CIRCUIT TO A CANNULA, AND WAS REPLACED AFTER THE INCIDENT." ALTHOUGH ADDITIONAL INFORMATION WAS REQUESTED, NONE HAS BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROBORE EXTENSION SET W/LL T-CONNECTOR ADMINISTRATION SET FPA ABBOTT LABORATORIES NA 81614VM

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other