BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTER

    MDR report key: 22119030 · Received May 30, 2025

    Report

    Report Number
    3006948883-2025-00166
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 3, 2025
    Report Date
    June 10, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    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 ANY SAMPLES OR PHOTOS, AND THE SPECIFIC DEFECT DETAILS COULD NOT BE IDENTIFIED. 2. QUERY BATCH RECORD INFORMATION: 1) THE COMPLAINT BATCH NUMBER 4050662 WAS PRODUCED ON THE PRN AUTOMATIC ASSEMBLY LINE, WITH THE PRODUCTION DATE OF 2024-4. 2024-4 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 AND THE MACHINE MAINTENANCE, AND FIND NO ABNORMALITIES, DEVIATIONS OR REWORK ACTIVITIES. 3. ANALYSIS OF THE RETAINED SAMPLE PRODUCTS: LEAKAGE TESTS WERE CONDUCTED ON THE RETAINED SAMPLE PRODUCTS OF THE SAME BATCH (ROTATE THE PRN ON THE STANDARD RUHR JOINT, INJECT THE STANDARD WATER PRESSURE, AND OBSERVE WHETHER THERE ARE ANY ABNORMALITIES IN THE PRN WITHIN THE STANDARD TIME). THE TEST RESULTS WERE QUALIFIED. 4. ROOT CAUSE ANALYSIS: LEAKAGE TESTS WERE CONDUCTED ON THE RETAINED SAMPLES OF THE SAME BATCH. THE TEST RESULTS WERE QUALIFIED, AND THE DEFECT PATTERNS COULD NOT BE REPRODUCED. AS NO SAMPLES OR PHOTOS WERE RETURNED, THE SPECIFIC DEFECT DETAILS COULD NOT BE IDENTIFIED. 5. THE FACTORY KEEPS A CLOSE EYE ON SUCH DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRN ADAPTER COMPONENT DAMAGED AND LEAKED ON (B)(6) 2025, AT 9:30 A.M., WHEN A DISPOSABLE PRN WAS INSTALLED FOR POSTOPERATIVE INFUSION, THE RUBBER TIP OF THE PRN BROKE, CAUSING FLUID TO LEAK OUT. THE DISPOSABLE PRN WAS IMMEDIATELY REPLACED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26733 BD PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4050662 00382903886388

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown