BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRN ADAPTER

    MDR report key: 25057257 · Received May 1, 2026

    Report

    Report Number
    3006948883-2026-00309
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    March 28, 2026
    Report Date
    May 6, 2026
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FMG
    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

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 5203369. 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. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    THE PATIENT WAS RECEIVING AN IV INFUSION VIA AN INDWELLING CATHETER. DUE TO CERTAIN CIRCUMSTANCES, THE HEPARIN CAP WAS REPLACED, AND FIVE MINUTES INTO THE INFUSION, IT WAS DISCOVERED THAT THE SOLUTION WAS LEAKING FROM THE MIDDLE SECTION OF THE HEPARIN CAP.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151610 PRN ADAPTER STOPCOCK, I.V. SET FMG BD SUZHOU (MDS) 5203369

    Patients

    Seq Age Sex Outcome Treatment
    1