BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET W/LL T-CONNECTOR

    MDR report key: 433687 · Received December 16, 2002

    Report

    Report Number
    9610175-2002-00014
    Event Type
    Malfunction
    Date Received
    December 16, 2002
    Date of Event
    November 27, 2002
    Report Date
    November 27, 2002
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM AN ABBOTT AFFILIATE WHICH INDICATES THE REPORTER NOTICED LEAKING OF BLOOD FROM THE SPACE BETWEEN THE SHRINK COVER AND THE RUBBER. THERE WAS NO DISCONNECTION OF THE RUBBBER, AND APPROX 1ML OF BLOOD LEAKED. THE REPORTER NOTICED THE INCIDENT WHEN THEY WERE FLUSHING WITH SALINE AFTER A BLOOD TRANSFUSION. THEY REPORTED THAT THERE WAS NO LEAKAGE DURING THE BLOOD TRANSFUSION PROCEDURE. THE PROCEDURE WAS NOT USED UNDER HIGH PRESSURE. THERE WAS NO PT HARM. ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    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 89-786-VM

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other