BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTER

    MDR report key: 19776472 · Received July 18, 2024

    Report

    Report Number
    3002601200-2024-00328
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 22, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FPA
    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. NO DEFECT SAMPLE RETURNED SAMPLE AND PICTURES FROM THE CUSTOMER 2. REVIEW BATCH RECORD INFORMATION, 1 THE COMPLAINT LOT 3052879 WAS PRODUCED IN THE PRN AUTOMATIC ASSEMBLY LINE, THE PRODUCTION DATE IS 2023-03, AND THE M860 PACKAGING MACHINE WAS PACKAGED IN 2023-03, AND THE BATCH OF PRODUCTS TOTALED (B)(4). 2 - CHECK THE PROCESS INSPECTION AND SHIPMENT INSPECTION REPORT OF THIS BATCH OF PRODUCTS. THE TEST RESULTS MEET THE PRODUCT STANDARDS AND THERE IS NO ABNORMALITY. 3 - CHECK THE PRODUCTION RECORDS AND MACHINE MAINTENANCE OF THIS BATCH OF PRODUCTS, AND THERE ARE NO ABNORMALITIES, DEVIATIONS OR WORK ACTIVITIES. 3. PERFORMED THE LEAKAGE TEST FOR THE RETAINED SAMPLE OF THE COMPLAINT LOT, (PUT THE RETAINED SAMPLE ON THE STANDARD LUER CONNECTOR. INJECT THE STANDARD PRESSURE IN IT. THEN CHECK WHETHER LEAKAGE AT THE CONNECTOR POSITION, THE TEST RESULT IS THAT NO ABNORMALITY ON THE RETAINED SAMPLE. 4. DUE TO NO SAMPLES RETURNED. THE ROOT CAUSE CANNOT BE CONFIRMED. 5. THE PLANT CONTINUE PAY ATTENTION TO THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD PRN ADAPTER LEAKED ON (B)(6) 2024, A NURSE IN THE THIRD WARD FOUND A SMALL AMOUNT OF LIQUID LEAKING FROM THE JOINT WHEN USING THE DISPOSABLE HEPARIN CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1646030 BD PRN ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BD SUZHOU (MDS) 3052879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown