BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMS/DELTEC, INC.

    MDR report key: 230280 · Received May 27, 1999

    Report

    Report Number
    230280
    Event Type
    Injury
    Date Received
    May 27, 1999
    Date of Event
    April 25, 1999
    Report Date
    April 28, 1999
    Manufacturer
    SIMS DELTEC, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RN CALLED AND REPORTED THAT THE PT'S LINE WAS BLEEDING AND LEAKING FLUID FROM HIS IV. UPON INSPECTION, LEAKAGE WAS DUE TO A UNK BREAKAGE AT THE MALE LUER LOCK THAT CONNECTS TO THE PT'S CENTRAL LINE. PT HAS NO KNOWLEDGE OF HOW THE BREAKAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMS/DELTEC, INC. CADD ADMINISTRATION SET #7034 FPA SIMS DELTEC, INC. NA 64858

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention