BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTER

    MDR report key: 18238133 · Received November 30, 2023

    Report

    Report Number
    3014704491-2023-00776
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 1, 2023
    Report Date
    January 4, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FPA
    UDI-DI
    00382903886388
    PMA / PMN Number
    NA
    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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. NO SAMPLE WERE RETURNED; 2.REVIEW BATCH RECORD INFORMATION, 1) THE COMPLAINT LOT#2286528 WAS PRODUCED IN THE PRN AUTOMATIC ASSEMBLY LINE, THE PRODUCTION DATE IS 2022-12, AND THE M860 PACKAGING MACHINE WAS PACKAGED IN 2022-12, 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. PERFORM THE FUNCTION TEST ON THE RETAINED SAMPLE OF THE COMPLAINT LOT: 1) PULL FORCE TEST. 2) LEAKAGE TEST. THE TEST RESULT IS PASSED, SEE THE ATTACHMENT1- TEST REPORT OF RETAINED SAMPLE. 4.ROOT CAUSE CANNOT BE CONFIRMED. 5. THE PLANT CONTINUE PAY ATTENTION TO THIS DEFECT. H3 OTHER TEXT : SEE NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRN ADAPTER ADAPTOR/CONNECTOR IS DEFECTIVE /DAMAGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; INTERVENTIONAL SURGERY CENTER TO THE HEPATIC ARTERY ANGIOGRAPHY HEPATIC ARTERY CANNULATION, TO THE HEPARIN CAP AND TUBING BACK TO THE HOSPITAL AREA MICROPUMP MAINTENANCE TO CONTINUE TO HIT THE DRUG, HIT THE DRUG ON THE WAY TO THE HEPARIN CAP BURST, THE RUBBER DIRECTLY WITH THE MAIN BODY SEPARATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884089 BD PRN ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BD (SUZHOU) 2286528 00382903886388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown