BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 19726137 · Received July 11, 2024

    Report

    Report Number
    9610847-2024-00189
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    May 13, 2024
    Report Date
    July 30, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    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

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 3093406. 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.

    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 CLOSED LUER ACCESS DEVICE LEAKED ON (B)(6) 2024, DUE TO THE CONDITION OF AN ONCOLOGY PATIENT, THE NURSE INSTALLED AN INFUSION PORT AND USED A SEPARATION MEMBRANE NEEDLE-FREE CLOSED INFUSION CONNECTOR FOR INFUSION. HALF AN HOUR AFTER THE START OF THE INFUSION, THE PATIENT'S FAMILY FOUND THAT THE PATIENT'S CLOTHES WERE SOAKED. THE NURSING STAFF RUSHED TO THE BED AND FOUND THAT THE INFUSION CONNECTOR WAS LEAKING. THEY IMMEDIATELY REPLACED THE INFUSION CONNECTOR TO ENSURE THAT THE PATIENT CONTINUED THE INFUSION TREATMENT; THIS EXTENDED THE PATIENT'S TREATMENT TIME, CAUSED A WASTE OF THE PATIENT'S MEDICINE, AND SOAKED THE PATIENT'S CLOTHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314878 BD Q-SYTE CLOSED LUER ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3093406 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown