BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 22772473 · Received August 11, 2025

    Report

    Report Number
    1710034-2025-01317
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 24, 2025
    Report Date
    August 21, 2025
    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
    WA, US
    Reporter Occupation
    NURSE
    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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382533 AND LOT NUMBER 5111217. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC BLOOD CONTROL FEATURE DID NOT WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEW IVS HAVE NO SAFETY FOR BLOOD RETURN. WHEN TRYING TO DRAW LABS BLOOD LEAKED ALL OVER PATIENT, BEDDING, BAIR HUGGER AND MY SHOES. I APPLIED PRESSURE AT SITE BUT BLOOD KEPT POURING OUT. THE NEW EXTENSIONS DO NOT EASILY CONNECT TO IV HUB SO YOU HAVE TO PUSH AND TURN WHICH TWIST THE PATIENTS SKIN AND CAUSES FLANGE ON IV HUB TO TURN TOWARDS SKIN WHICH IS UNCOMFORTABLE FOR PATIENT AND CAN POTENTIALLY CAUSE SKIN BREAKDOWN." GIVE US BACK THE IV'S WE ORIGINALLY HAD. THEY ARE SAFER-LESS BLOOD EXPOSURE, LESS TIME CLEANING UP PT AND BEDDING. LAB DRAWS ARE EASIER AND TAKE LESS TIME. THE SAFETY OF THE PATIENTS AND STAFF NEEDS TO BE A PRIORITY. 1. DATE OF EVENT: (B)(6) 2025. 2. NO PATIENT HARM, BUT BLOOD LEAKED ALL OVER THE PATIENT, BEDDING, BAIR HUGGER AND NURSE¿S SHOES.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034543 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5111217 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown