BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET W/LL T-CONNECTOR

    MDR report key: 321839 · Received March 15, 2001

    Report

    Report Number
    9610175-2001-00005
    Event Type
    Malfunction
    Date Received
    March 15, 2001
    Date of Event
    January 24, 2001
    Report Date
    February 12, 2001
    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 INT'L AFFILIATE (ABBOTT UK) THAT STATES, "TUBING BECAME DISCONNECTED FROM T-PIECE DURING USE. BLOOD AND LIQUID WERE NOTICED ON TROLLEY." A GRASEBY 3500 SYRINGE DRIVER WAS IN USE AT THE TIME OF EVENT. THE TUBING WAS REPORTEDLY REPLACED. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. ADD'L INFO RECEIVED INDICATED THAT THE TUBING DICONNECTED FROM THE "BONDED PORTION BETWEEN THE EXTENSION TUBING AND T-CONNECTOR". THERE WAS NO OTHER INFO AVAILABLE, THOUGH REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11557 MICROBORE EXTENSION SET W/LL T-CONNECTOR ADMINISTRATION SET FPA ABBOTT LABORATORIES NA 65421VM

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other SERIAL NUMBER NOT AVAILABLE.| GRASEBY 3500 SYINGE DRIVER,