BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PRN ADAPTER

    MDR report key: 16114011 · Received January 6, 2023

    Report

    Report Number
    3014704491-2022-00729
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 5, 2022
    Report Date
    January 17, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FPA
    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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2073071. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ PRN ADAPTER EXPERIENCED LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE PATIENT WAS INFUSED, THE HEPARIN CAP ON THE HEMATOMA CAVITY DRAINAGE TUBE WAS FOUND TO LEAK, AND THE HEPARIN CAP WAS REPLACED IN TIME, WHICH DID NOT CAUSE SUBSTANTIAL HARM TO THE PATIENT OR AFFECT THE TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ PRN ADAPTER EXPERIENCED LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE PATIENT WAS INFUSED, THE HEPARIN CAP ON THE HEMATOMA CAVITY DRAINAGE TUBE WAS FOUND TO LEAK, AND THE HEPARIN CAP WAS REPLACED IN TIME, WHICH DID NOT CAUSE SUBSTANTIAL HARM TO THE PATIENT OR AFFECT THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238886 BD¿ PRN ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 2073071

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown