BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRN ADAPTER

    MDR report key: 24279227 · Received February 6, 2026

    Report

    Report Number
    3006948883-2026-00067
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 4, 2026
    Report Date
    March 4, 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 RESULTS: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 5203385. 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

    ON (B)(6) 2026, 1:40 PM: WHILE CHANGING BED LINENS, THE PATIENT'S FAMILY NOTICED DAMP CLOTHING AND IMMEDIATELY CALLED THE ON-DUTY NURSE. THE NURSE PROMPTLY ARRIVED TO INVESTIGATE AND CONFIRMED THE DAMPNESS RESULTED FROM A SLOW LEAK OF MEDICATION (FAT EMULSION AMINO ACID GLUCOSE INJECTION) AT THE HEPARIN CAP CONNECTED TO THE PATIENT'S IV PORT NEEDLE. THIS HEPARIN CAP HAD BEEN NEWLY REPLACED AT 8:00 AM THAT SAME DAY. THE NURSE PROMPTLY REPLACED THE HEPARIN CAP WITH A NEW STERILE ONE, ENSURING A SECURE CONNECTION AND UNOBSTRUCTED TUBING. THIS INCIDENT RESULTED IN MEDICATION WASTE BUT CAUSED NO HARM TO THE PATIENT AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337144 PRN ADAPTER STOPCOCK, I.V. SET FMG BD SUZHOU (MDS) 5203385

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown