BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRN ADAPTER

    MDR report key: 19584950 · Received June 21, 2024

    Report

    Report Number
    3014704491-2024-00062
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 19, 2024
    Report Date
    June 25, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    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 DEFECT SAMPLE RETURNED, THE DETAIL CRACK SITUATION CANNOT BE IDENTIFIED. 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 (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. CHECK THE APPEARANCE OF THE RETAINED SAMPLE. (B)(4) PCS. NO OBSERVED THE CRACK OF PRN ON THE RETAINED SAMPLE. 4. ROOT CAUSE: DUE TO NO SAMPLE RETURNED, THE DETAIL CRACK SITUATION CANNOT BE IDENTIFIED, ROOT CAUSE CANNOT BE CONFIRMED. 5. THE PLANT CONTINUE PAY ATTENTION TO THIS DEFECT.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    CRACKS WERE FOUND AT THE TAIL OF THE HEPARIN CAP DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218493 PRN ADAPTER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 3171232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown