BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROBORE EXTENSION SET W/LL T-CONNECTOR

    MDR report key: 239110 · Received September 3, 1999

    Report

    Report Number
    6000097-1999-00009
    Event Type
    Injury
    Date Received
    September 3, 1999
    Date of Event
    June 2, 1999
    Report Date
    August 4, 1999
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DISCONNECTION WITH BLOOD LOSS REPORTED. REPORT RECEIVED FROM ABBOTT INTERNATIONAL AFFILIATE, ABBOTT UK, STATES: "SLIP LOCK T-PIECE BECAME DISCONNECTED FROM CANNULA. PT LOST EST. 30MLS BLOOD. BABY APPEARED TO HAVE CAUSED DISCONNECTION BY SUCKING. BABY GIVEN BOLUS OF 30MLS 0.9% SALINE AND 38MLS PACKED CELLS OVER 2 HRS. PT RECOVERED." ADDITIONAL INFO HAS BEEN REQUESTED. IF ANY FURTHER INFO BECOMES AVAILABLE, IT WILL BE FORWARDED TO THE AGENCY.

    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 48124VM

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY Required Intervention