BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE

    MDR report key: 22566329 · Received July 22, 2025

    Report

    Report Number
    9610847-2025-00227
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 27, 2025
    Report Date
    August 19, 2025
    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: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385102 AND LOT NUMBER 4211134. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    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 COMPONENT WAS DAMAGED 1. SPECIFIC OPERATING CONDITIONS: IN THE EMERGENCY INTENSIVE CARE UNIT RUPTURED THE SEPTUM WHILE SEPARATING THE SEPTUM AND INFUSION DEVICE FOR A PATIENT. 2. ADVERSE EVENT: THE SEPTUM RUPTURED WHILE SEPARATING THE SEPTUM AND INFUSION DEVICE. 3. IMPACT ON THE VICTIM: THE RUPTURE WAS DISCOVERED IN A TIMELY MANNER AND NO HARM WAS CAUSED. 4. TREATMENT MEASURES TAKEN AND RESULTS: THE SEPTUM WAS REPLACED WITH A NEW ONE IN A TIMELY MANNER, AND THE ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2294855 Q-SYTE STOPCOCK, I.V. SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 4211134 00382903851027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown