BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE

    MDR report key: 23997395 · Received January 7, 2026

    Report

    Report Number
    9610847-2025-00492
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    November 29, 2025
    Report Date
    February 25, 2026
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00382903851027
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE SINCE NO PHOTO NOR SAMPLE WAS PROVIDED TO PERFORM A PROPER INVESTIGATION. AN INVESTIGATION ON THE ACTUAL DEVICE WOULD BE NECESSARY TO CONFIRM THE REPORTED FAILURE MODE. QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES BUT ISSUES LIKE THIS ARE NOT DETECTED WHICH MEANS PRETTY LOW OCCURRENCE. WE WILL KEEP MONITORING THE MANUFACTURING PROCESS AND IN CASE ANY EMERGING TREND IS DETECTED, FURTHER ACTIONS WILL BE TAKEN IF NECESSARY. NO RELATED QUALITY ISSUES OR DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCHES.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE HAD CONNECTION ISSUES THE PATIENT, DIAGNOSED WITH NRDS AND PREMATURE INFANT DISEASE, WAS ADMINISTERED A NEEDLE-FREE CLOSED INFUSION CONNECTOR WITH A DIAPHRAGM VALVE MANUFACTURED BY BD MEDICAL DEVICES (SHANGHAI) CO., LTD. ON (B)(6) 2025. AT 9:00 AM THAT DAY, DURING ROUTINE LONG-TERM TREATMENT, THE TEMPORARY FLUID CONNECTOR WAS REMOVED, REVEALING A MALFUNCTION WHERE ONE SIDE OF THE DIAPHRAGM VALVE WAS INDENTED AND FAILED TO REBOUND. UPON LEARNING OF THIS, THE NURSE TOOK CORRECTIVE MEASURES, INCLUDING REPLACING THE DIAPHRAGM VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58190 Q-SYTE STOPCOCK, I.V. SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 4180049 00382903851027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown