BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20885010 · Received December 9, 2024

    Report

    Report Number
    1710034-2024-01460
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 8, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382533 AND LOT NUMBER 4093240. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC LEAKED AND AIR IN LINE DURING ASPIRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 20 GA IV CATHETER SHOWED SIGNS OF LEAKING WHERE THE CATHETER TUBE MEETS THE PLASTIC HUB. I WAS ABLE TO ACCESS THE PATIENT'S VEIN GREAT AND WHEN I BEGAN TO TEST FLUSH WITH SALINE, BY HAND, I NOTICED THE LEAK. WHEN I DREW BACK ON THE SALINE FLUSH YOU CAN SEE TINY AIR BUBBLES AND ACTUALLY HEAR THE AIR IN THE LINE. I REMOVED THE IV AND UNFORTUNATELY HAD TO START A NEW ONE. 22 NOV ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ADVERSE OUTCOME OTHER THAN PATIENT HAD TO BE INJECTED AGAIN. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 11-08-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2522220 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4093240 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown