BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21915523 · Received April 26, 2025

    Report

    Report Number
    1710034-2025-00685
    Event Type
    Malfunction
    Date Received
    April 26, 2025
    Date of Event
    January 25, 2025
    Report Date
    July 8, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF THE NEEDLE PUNCTURING THE IV CATHETER WAS CONFIRMED AND THE DAMAGE APPEARED TO BE ASSOCIATED WITH USE. ONE 22G INSYTE AUTOGUARD DEVICE FROM LOT 4212199 WAS PROVIDED FOR INVESTIGATION. THE IV CATHETER WAS RECEIVED SEPARATE FROM THE SHIELDED NEEDLE. A MICROSCOPIC EXAMINATION OF THE IV CATHETER REVEALED V-SHAPED BREACHES IN THE TUBING, WHICH WERE CONSISTENT WITH NEEDLE PUNCTURES. AS THE SAMPLE EXHIBITED EVIDENCE OF USE, THE CATHETER WAS LIKELY DAMAGED DURING THE INSERTION PROCESS. THE INSTRUCTIONS FOR USE (IFU) STATE, "IF THE NEEDLE IS PARTIALLY OR COMPLETELY WITHDRAWN FROM THE CATHETER TUBING DURING INSERTION, DO NOT RE-INSERT THE NEEDLE INTO THE CATHETER TUBING AS DAMAGE MAY OCCUR."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 KINKS OR BENDS WERE OBSERVED IN THE RETURNED IV CATHETER. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Additional Manufacturer Narrative · 0

    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 AUTOGUARD NEEDLE PIERCED THE CATHETER DUE TO NEEDLE DEFECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DESCRIPTION ANGIOCATH BENT DURING INSERTION ATTEMPT AND CATHETER WAS PUNCTURED BY NEEDLE. THIS OCCURRED WITH 2 ANGIOCATH, ONLY 1 AVAILABLE TO SEND TO PRODUCT RECALL TEAM. EVENT DATE 01/25/2025 PATIENT HARM NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502698 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4212199 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown