BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE

    MDR report key: 23797695 · Received December 13, 2025

    Report

    Report Number
    1710034-2025-01945
    Event Type
    Malfunction
    Date Received
    December 13, 2025
    Date of Event
    October 28, 2025
    Report Date
    December 31, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    UDI-DI
    00382903851003
    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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 5031462. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, 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 SIMILAR ISSUES 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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 5031462. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, 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.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE PATIENT WAS ADMITTED FOR ABDOMINAL PAIN AND ADMINISTERED INTRAVENOUS FLUIDS AS PRESCRIBED. DURING INTRAVENOUS INFUSION USING A NEEDLE-FREE CLOSED-SYSTEM INFUSION CONNECTOR WITH A SEPTUM, LEAKAGE WAS DETECTED IN THE SEPTUM, RENDERING IT UNUSABLE. THE DEVICE WAS IMMEDIATELY DISCONTINUED AND REPLACED WITH A NEW NEEDLE-FREE CLOSED-SYSTEM INFUSION CONNECTOR WITH A SEPTUM. FOLLOWING REPLACEMENT, THE PATIENT COMPLETED TREATMENT (OR EXAMINATION) WITHOUT INCIDENT. THIS ADVERSE EVENT RESULTED IN A DELAY IN THE PATIENT'S INFUSION THERAPY.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2696047 Q-SYTE PERIPHERAL IV CATHETERS FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5031462 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown