BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX ABS PRO-VENT

    MDR report key: 21415616 · Received February 19, 2025

    Report

    Report Number
    3012307300-2025-02031
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    January 1, 2025
    Report Date
    March 24, 2026
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JKA
    UDI-DI
    00351688060214
    PMA / PMN Number
    K952516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INCORRECTLY FILED UNDER THIS REGISTRATION NUMBER, PLEASE REFERENCE MRN 1217052-2026-00013-00 FOR DETAILS PERTINENT TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE FILTER PRO AND FROM THE GAPS IN THE SYRINGE WHEN BLOOD WAS DRAWN. THERE WERE NO PATIENT HARMS OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204169 PORTEX ABS PRO-VENT TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA SMITHS MEDICAL ASD, INC. 6020314 00351688060214

    Patients

    Seq Age Sex Outcome Treatment
    1