BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 19047524 · Received April 4, 2024

    Report

    Report Number
    1710034-2024-00288
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    December 12, 2023
    Report Date
    April 29, 2024
    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

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. 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. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE SEPTUM IS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE CHILD WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023. TO REMOVE THE INFUSION PORT, AND FOUND THAT THE SEPTUM OF THE INFUSION CONNECTOR WAS DEFORMED AND CONCAVE, AND COULD NOT BE CONNECTED TO THE SYRINGE PUNCH SEALING TUBE, AND A SMALL AMOUNT OF BLOOD FLOWED BACK, AND THAT THE SEPTUM OF THIS INFUSION CONNECTOR WAS DEFORMED AND CONCAVE, WHICH HAD THE RISK OF LEADING TO THE RISK OF RETROGRADE BLOOD INFECTION IN THE PORT OF THE INFUSION, AND THERE WAS A RISK OF PORT BLOCKAGE

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334729 BD Q-SYTE CLOSED LUER ACCESS DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3093406 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown