BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 21915491 · Received April 26, 2025

    Report

    Report Number
    1710034-2025-00679
    Event Type
    Malfunction
    Date Received
    April 26, 2025
    Date of Event
    April 16, 2025
    Report Date
    June 25, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    INVESTIGATION RESULTS: THE COMPLAINTS OF FLASHBACK AND BLOOD FLOW WERE CONFIRMED BASED ON THE CIRCUMSTANTIAL EVIDENCE THAT WAS OBSERVED IN THE PHOTOGRAPH AND ON THE PHYSICAL SAMPLE THAT WERE PROVIDED FOR INVESTIGATION. ONE SHIELDED NEEDLE WAS PROVIDED FOR INVESTIGATION ALONG WITH THREE TOP WEB LABELS FROM LOTS 4292357, 4303344, AND 5010456. THE LOT OF THE RETURNED SAMPLE COULD NOT BE DETERMINED. INSTEAD OF BEING CONTAINED WITHIN THE FLASHBACK CHAMBER, WHAT APPEARED TO BE BLOOD RESIDUE WAS OBSERVED THROUGHOUT THE GRIP AND BARREL, WHICH SUPPORTS THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT. THE LEAK PATH COULD NOT BE DETERMINED DUE TO THE DRIED BLOOD RESIDUE. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO RELATED ISSUES WITH THE MANUFACTURING PROCESS. THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IMMEDIATELY UPON ACCESSING THE VEIN THE FLASHBACK COMES ALL THE WAY OUT THE BACK END OF THE CATHETER-BLOOD BATH CUSTOMER REPORTED ON (B)(6) I FIRST REPORTED THE ISSUE (B)(6) 2025 AND WE HAVE HAD CONSISTENT ISSUES SINCE THAT TIME. THERE HAS BEEN NO HARM TO STAFF OR PATIENTS BUT A LOT OF SOILED LINENS, SCRUBS AND SHOES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276856 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5010456 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown