BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTER

    MDR report key: 22151609 · Received June 5, 2025

    Report

    Report Number
    3006948883-2025-00187
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    May 13, 2025
    Report Date
    June 26, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FPA
    UDI-DI
    00382903886388
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER DID NOT RETURN THE SAMPLES OR PHOTOS, MAKING IT IMPOSSIBLE TO CONFIRM THE DEFECT SITUATION. 2. QUERY BATCH RECORD INFORMATION. 1)THE COMPLAINT BATCH NUMBER # 4050662 WAS PRODUCED ON THE PRN AUTOMATIC ASSEMBLY LINE, WITH THE PRODUCTION DATE OF 2024-3. 2024-3 WAS PACKAGED ON THE M860 PACKAGING MACHINE. THE TOTAL VALUE OF THIS BATCH OF PRODUCTS IS 439.6K. 2) CHECK THE PROCESS INSPECTION AND SHIPMENT INSPECTION REPORTS OF THIS BATCH OF PRODUCTS. THE TEST RESULTS ALL MEET THE PRODUCT STANDARDS AND THERE ARE NO ABNORMALITIES. 3) CHECK THE PRODUCTION RECORDS OF THIS BATCH OF PRODUCTS. 3. ANALYSIS OF THE RETAINED SAMPLE PRODUCTS: LEAKAGE TESTS WERE CONDUCTED ON THE RETAINED SAMPLE PRODUCTS OF THE SAME BATCH, AND THE TEST RESULTS WERE QUALIFIED. 4. ROOT CAUSE ANALYSIS: AFTER ANALYSIS AND INVESTIGATION, IT WAS FOUND THAT THE ISSUE MIGHT BE DUE TO THE FIT BETWEEN THE PRN AND OTHER COMPONENTS. BASED ON THE APPEARANCE AND LEAKAGE TESTS OF THE INTERNAL SAMPLES, THE CONNECTION PROCESS WAS NORMAL AND NO PROBLEMS OCCURRED. A COMPREHENSIVE ANALYSIS SUGGESTS THAT THE PROBLEM MIGHT BE CAUSED BY THE CONNECTOR ITSELF. 5. THE FACTORY WILL CONTINUE TO PAY ATTENTION TO THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRN ADAPTER HAD CONNECTION ISSUES. THE PATIENT WAS GIVEN ANTIBIOTICS FOR HIGH INFLAMMATION, AND WHEN THE TUBE WAS ABOUT TO BE CLOSED AFTER TREATMENT, IT WAS FOUND THAT THE HEPARIN CAP COULD NOT BE SCREWED ONTO THE CONNECTOR. IMMEDIATE REPLACEMENT WITH A NEW CONSUMABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77129 BD PRN ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BD SUZHOU (MDS) 4050662 00382903886388

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown