BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21509717 · Received March 3, 2025

    Report

    Report Number
    1710034-2025-00349
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 17, 2025
    Report Date
    April 30, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814442
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D. POTENTIAL LOT (BATCH) #S PROVIDED: OUR BEST GUESS IS EITHER LOT # 4222173 OR 4310980 BASED ON UNUSED PRODUCT IN STORAGE. 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: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. YOUR REPORT OF A LEAK WAS CONFIRMED, AND THE CAUSE WAS ATTRIBUTABLE TO A CIRCUMFERENTIAL CRACK IN THE GREEN CATHETER ADAPTER, WHICH APPEARED TO BE MANUFACTURING RELATED. THE ADAPTER WAS INTACT AND IN ONE PIECE; HOWEVER, THE ADAPTER WAS BROKEN, AND THE PLANE OF THE BREAK WAS ADJACENT TO THE PUSH TAB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD CRACK IN HUB WITH BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE IV CATHETER WAS INSERTED INTO THE PATIENT IT STARTED LEAKING BLOOD AROUND THE GREEN HUB PART OF THE CATHETER. IT WAS DISCOVERED THAT THE GREEN HUB HAD A CRACK THROUGH IT. CUSTOMER RESPONSE ON (B)(6) 2025. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? 02-17-25 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. PATIENT REQUIRED A SECOND VENIPUNCTURE TO BE PERFORMED DUE TO FAILURE OF THE INITIAL CATHETER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147353 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903814442

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown