BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET W/LL T-CONNECTOR

    MDR report key: 362934 · Received November 23, 2001

    Report

    Report Number
    9610175-2001-00022
    Event Type
    Malfunction
    Date Received
    November 23, 2001
    Date of Event
    October 19, 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

    RECEIVED REPORT FROM ABBOTT INT'L AFFILIATE (ABBOTT-CANADA) WHICH STATES" THE PT HAD AN INTRAVENOUS LINE INFUSING WITH A MICROBORE T-SET. THE ACCESS DEVICE WAS IN THE HAND. MICROBORE SET WAS USED IN THE PT UNIT. PT WAS FOUND TO HAVE REDNESS AT THE SITE WHERE THE LUER LOCK, SPIN COLLAR WAS RESTING. NO OTHER EFFECTS TO THE PT BESIDES THE REDNESS." 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
    53011 MICROBORE EXTENSION SET W/LL T-CONNECTOR ADMINISTRATION SET FPA ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other