BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21786774 · Received April 7, 2025

    Report

    Report Number
    1710034-2025-00525
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 11, 2025
    Report Date
    May 20, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    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 COMPLAINT THAT THE NEEDLE PIERCED THE IV CATHETER WAS CONFIRMED AND THE CAUSE APPEARED TO BE ASSOCIATED WITH USE. TWO PHOTOGRAPHS WERE PROVIDED FOR INVESTIGATION, WHICH SHOWED THE NEEDLE PROTRUDING THROUGH THE SIDE OF A 22G INSYTE AUTOGUARD IV CATHETER. THE SAMPLE EXHIBITED EVIDENCE OF USE. DUE TO THE PRESENCE OF WHAT APPEARED TO BE BLOOD RESIDUE BETWEEN THE CATHETER TIP AND THE NEEDLE PUNCTURE SITE, IT APPEARED THAT THE CATHETER WAS ABLE TO ACCESS THE VESSEL. THE NEEDLE LIKELY PUNCTURED THE TUBING AFTER INSERTION. THE INSTRUCTIONS FOR USE (IFU) STATE, "IF THE NEEDLE IS PARTIALLY OR COMPLETELY WITHDRAWN FROM THE CATHETER TUBING DURING INSERTION, DO NOT RE-INSERT THE NEEDLE INTO THE CATHETER TUBING AS DAMAGE MAY OCCUR." NO DEFECTS ASSOCIATED WITH THE MANUFACTURING PROCESS COULD BE IDENTIFIED FROM THE PHOTOGRAPH. MANUFACTURING CONTROLS ARE IN PLACE TO MITIGATE THE OCCURRENCE OF THIS TYPE OF FAILURE. 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 AUTOGUARD NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD ANOTHER REPORT OF AN IV CATH MALFUNCTION. THIS ONE WAS AT SFB AND IT LOOKS LIKE THE NEEDLE SPLIT DOWN THE MIDDLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956914 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4291271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown