BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX SMALL BORE EXTENSION SET W/ THREE-WAY STOPCOCK

    MDR report key: 21335231 · Received February 7, 2025

    Report

    Report Number
    9616567-2025-00022
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 15, 2025
    Report Date
    April 9, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPK
    UDI-DI
    10351688507563
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INCORRECTLY FILED UNDER THIS REGISTRATION NUMBER, PLEASE REFERENCE MRN 1526863-2025-00034-00 FOR DETAILS PERTINENT TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    D4. PRIMARY UDI NUMBER: THE PRIMARY DI# HAS BEEN USED AS THE LOT/SERIAL INFORMATION IS UNKNOWN. H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOVASCULAR INTENSIVE CARE UNIT EXPERIENCED FOUR INSTANCES OVER A FEW DAYS WHERE THE DEVICE BROKE AT THE CONNECTION BETWEEN THE TUBING PIGTAIL AND THE 3-WAY STOPCOCK. THESE BREAKS RESULTED IN BLOOD SPILLS ON THE PATIENT, THEIR BEDS, AND THE FLOORS. THE EVENT OCCURRED ON (B)(6) 2025 AT 5 PM DURING USE ON THE PATIENT. THERE WAS MEDICATION BEING USED WITH THE PRODUCT AND THERE WAS DELAY IN THERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881355 MEDEX SMALL BORE EXTENSION SET W/ THREE-WAY STOPCOCK TUBING, FLUID DELIVERY FPK SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. UNKNOWN 10351688507563

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown