BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTER

    MDR report key: 19322727 · Received May 15, 2024

    Report

    Report Number
    3002601200-2024-00182
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 27, 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 SAMPLE RETURNED 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, 04, AND THE PACKAGING MACHINE WAS PACKAGED IN 2023, 04 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 REWORK ACTIVITIES. 3. PERFORMED THE LEAKAGE TEST ON THE RETAINED SAMPLE OF COMPLAINT LOT , THE TEST RESULT IS PASS , SEE THE ATTACHMENT 1 - TEST REPORT OF RETAINED SAMPLE ; 4. ROOT CAUSE : DUE TO NO SAMPLE 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 THAT BD PRN ADAPTER ADAPTER/ CONNECTOR WAS DEFECTIVE / DAMAGED NURSE PERFORMS AN INFUSION PROCEDURE WHERE THE HEPARIN CAP IS CONNECTED TO THE INDWELLING NEEDLE AND THERE IS OOZING AT THE INTERFACE, REPLACING THE INDWELLING NEEDLE AND HEPARIN CAP WITH A NEW ONE. OOZING FLUID, DETECTED IN TIME, DID NOT CAUSE INJURY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519350 BD PRN ADAPTER STOPCOCK, I.V. SET FPA BD SUZHOU (MDS) 3052879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown