BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE

    MDR report key: 22537904 · Received July 17, 2025

    Report

    Report Number
    1710034-2025-01204
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 30, 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

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 4213935. 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

    IT WAS REPORTED THAT BD Q-SYTE WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2025, A PATIENT WITH LIVER CANCER WAS BEDRIDDEN WITH UNSTABLE VITAL SIGNS AND RECEIVING 24-HOUR INFUSION. AT 16:30, DURING A WARD ROUND, THE INFUSION CONNECTOR AND THE PATIENT'S BACK WERE FOUND TO BE WET. UPON INSPECTION, THE INFUSION CONNECTOR WAS FOUND TO BE DAMAGED AND FLUID WAS SEEPING FROM THE CONNECTOR. IT WAS IMMEDIATELY REPLACED, AND NO FURTHER LEAKAGE WAS OBSERVED AFTER REPLACEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711218 Q-SYTE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4213935 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown