BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 19755706 · Received July 16, 2024

    Report

    Report Number
    1710034-2024-00731
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 19, 2024
    Report Date
    August 6, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 382523 AND LOT NUMBER 4082073. 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. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER. E1. NJ WAS USED AS THE STATE AS THE CUSTOMER HAS NOT PROVIDED THIS INFORMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC BLU 22GA X 1.0IN LEAKED AT HUB/IV TUBING CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER LEAKING AT HUB. (B)(6). THE 22GAUGE IV CATHETERS HAVE BEEN LEAKING AT THE CONNECTION OF THE HUB OF THE CATHETER AND THE IV TUBING. IT LOOKS AND FEELS LIKE THE WINGS DON¿T FULLY ENGAGE ANYMORE INTO THE TUBING. WE CHANGE THE TUBING AND THE PROBLEM DOES NOT IMPROVE. IF WE START A NEW IV AND USE THE SAME TUBING IT DOESN¿T LEAK. IT SEEMS LIKE SOME CATHETER HUBS HAVE A ILL FITTING CONNECTION. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505318 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4082073 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown