BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET W/LL T-CONNECTOR

    MDR report key: 362941 · Received November 23, 2001

    Report

    Report Number
    9613251-2001-00101
    Event Type
    Malfunction
    Date Received
    November 23, 2001
    Date of Event
    October 1, 2001
    Report Date
    October 19, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM ABBOTT INT'L AFFILAITE (ABBOTT-CANADA) WHICH STATES "THE INCIDENT OCCURRED ON A PT UNIT WITH A PT. THE PT HAD AN INTRAVENOUS LINE INFUSING WITH A MICROBORE T-SET. THE ACCESS DEVICE WAS IN THE HAND. THE PT WAS FOUND TO HAVE AN OPEN LESION AT THE SITE WHERE THE LUER LOCK, SPIN COLLAR WAS RESTING. THE LESION WAS TREATED WITH ANTIBIOTIC CREAM PRESCRIBED BY THE TREATING PHYSICIAN. THERE WAS NO FURTHER CONSEQUENCE NOTED." ADD'L PT AND EVENT INFO HAS BEEN REQUESTED, BUT NO FURTHER INFO HAS BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53014 MICROBORE EXTENSION SET W/LL T-CONNECTOR ADMINISTRATION SET FPA ABBOTT LABORATORIES NA 75-099-NS

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other