BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTER

    MDR report key: 20281220 · Received September 23, 2024

    Report

    Report Number
    3002601200-2024-00453
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 2, 2024
    Report Date
    October 1, 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

    1. NO SAMPLE RETURNED , NO DEFECT SAMPLE WAS RETURNED ; 2. REVIEW BATCH RECORD INFORMATION, 1) THE COMPLAINT LOT#3171232 WAS PRODUCED IN THE PRN AUTOMATIC ASSEMBLY LINE, THE PRODUCTION DATE IS 2023-07, AND THE M860 PACKAGING MACHINE WAS PACKAGED IN 2023-07, AND THE BATCH OF PRODUCTS TOTALED 439.6K; 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 REWORK ACTIVITIES. 3. RETAINED SAMPLE ANALYSIS : PERFORMED THE LEAKAGE TEST ON THE RETAINED SAMPLE OF COMPLAINT LOT, THAT IS ROTARY THE PRN OF RETAINED SAMPLE ON THE STANDARD LUER CONNECTOR , THEN INJECTED THE SYSTEM WATER PRESSURE , OBSERVED WHETHER ABNORMALITY ON THE SAMPLE REPORT OF COMPLAINT LOT. 4. ROOT CAUSES ANALYSIS: DUE TO NO SAMPLE WAS RETURNED , CANNOT CONFORM THE SAMPLE , THE FAILURE MODE CANNOT BE REPRODUCED , THE ROOT CAUSE CANNOT BE CONFORMED ; 5. THE PLANT CONTINUE PAY ATTENTION TO THIS DEFECT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRN ADAPTER HAD A LOOSE COMPONENT AND LEAK. ON (B)(6) 2024, AT 15:30 THE NURSE MADE WARD ROUNDS TO CHECK THAT THE PATIENT'S INFUSION HAD BEEN COMPLETED, AND WHEN FLUSHING THE TUBE WITH SALINE, SHE FOUND THAT THE SINGLE-USE HEPARIN CAP COULD NOT BE FULLY TIGHTENED, AND THERE WAS EXTRAVASATION OF FLUID AROUND THE EDGES, WHICH COULD INCREASE THE RISK OF INFECTION. REPORT TO THE NURSE MANAGER AND THE EQUIPMENT DEPARTMENT TO RE-REPLACE THE PATIENT'S SINGLE-USE HEPARIN CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591258 BD PRN ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BD SUZHOU (MDS) 3171232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown