BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE

    MDR report key: 22680830 · Received July 31, 2025

    Report

    Report Number
    1710034-2025-01269
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    June 26, 2025
    Report Date
    August 7, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    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

    AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    D4. THE LOT NUMBER PROVIDED 240502, DOES NOT CORRESPOND TO THE ANY MATERIAL NUMBER WITH THE ASSOCIATED REPORTED DEVICE. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2025, AFTER THE PICC CATHETER WAS MAINTAINED, A NEW SEPARATOR MEMBRANE NEEDLELESS CLOSED INFUSION NEEDLE WAS REPLACED, AND LIQUID SEEPED FROM THE GAP IN THE INTERFACE. IT MAY CAUSE BLOODSTREAM INFECTION, AND A NEW SEPARATOR MEMBRANE NEEDLELESS CLOSED INFUSION CONNECTOR IS REPLACED. PATIENT HARM: NONE. UNABLE TO DETERMINE PRODUCT QUALITY ISSUES. REPLACE THE NEW SEPARATOR MEMBRANE. NEEDLELESS CLOSED INFUSION CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198446 BD Q-SYTE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown