BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTATIC Y SETS

    MDR report key: 21117995 · Received January 9, 2025

    Report

    Report Number
    9616567-2025-00006
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    November 14, 2024
    Report Date
    April 22, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FCB
    UDI-DI
    10351688515568
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - EXPIRATION DATE, D4 - PRIMARY UDI NUMBER, H5 - LABELED FOR SINGLE USE AND H4 - DEVICE MFG DATE: CORRECTION. H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Additional Manufacturer Narrative · 0

    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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE SAMPLE CAP DETACHED WHEN LOOSENED. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324616 HEMOSTATIC Y SETS BAG, HEMOSTATIC FCB SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6034513 10351688515568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown