BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA THREE-WAY STOP COCK W/SWIVEL MALE LUER LOCK

    MDR report key: 3810464 · Received April 15, 2014

    Report

    Report Number
    2183502-2014-00214
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Report Date
    April 14, 2014
    Manufacturer
    SMITHS MEDICAL, INC
    Product Code
    FMG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. METHOD: A SAMPLE DEVICE WAS RETURNED AND IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE DEVICE BECAME DISASSEMBLED DURING USE. THE DRIP LINES IN USE AT THE TIME WERE REPLACED. THERE WAS NO REPORTED PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230535 ULTRA THREE-WAY STOP COCK W/SWIVEL MALE LUER LOCK FMG - STOPCOCKS AND MANIFOLDS FMG SMITHS MEDICAL, INC NA 2601490

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK