BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET W/LL T-CONNECTOR

    MDR report key: 330185 · Received April 30, 2001

    Report

    Report Number
    9610175-2001-00009
    Event Type
    Malfunction
    Date Received
    April 30, 2001
    Date of Event
    March 1, 2001
    Report Date
    March 27, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM ABBOTT INTERNATIONAL (ABBOTT-UK) WHICH STATES "TUBING DISCONNECTED FROM T DURING USE. CAUSING THE BABY TO LOSE A MODERATE AMOUNT OF BLOOD". ALTHOUGH REQUESTED, WHAT WAS INFUSING VIA THE DEVICE, IF ANY INTERVENTION WAS REQUIRED OR THE PATIENT'S EXACT AGE, GENDER AND DIAGNOSIS ARE UNKNOWN TO THE REPORTER. NO REPORT OF ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19837 MICROBORE EXTENSION SET W/LL T-CONNECTOR ADMINISTRATION SET FPA ABBOTT LABORATORIES NA 58-596-VM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other