BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 21200612 · Received January 21, 2025

    Report

    Report Number
    1710034-2025-00038
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    January 2, 2025
    Report Date
    March 31, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 400 UNITS OF 22GX1.00IN INSYTE AUTOGUARD DEVICES FROM MULTIPLE LOT NUMBERS. YOUR REPORT OF FOREIGN MATTER WAS ENTERED FOR MATERIAL 382523, LOT NUMBER 4155276. IN ADDITION TO RECEIVING 400 SAMPLES FROM LOT NUMBER 4155276, WE ALSO RECEIVED SAMPLES FROM LOT NUMBERS 4122757, 4037528 AND 4053903 WHICH WERE NOT REPORTED. A REPRESENTATIVE ATTEMPTED CONTACTING YOU REGARDING IF YOU EXPERIENCED AN ISSUE WITH THE ADDITIONAL SAMPLES RECEIVED. A SAMPLING OF 20 UNITS WERE RANDOMLY SELECTED FROM LOT NUMBER 4155276 FOR EXAMINATION. A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED SAMPLES REVEALED NO DAMAGE OR DEFECTS. NO LOOSE PIECES OF HARD PLASTIC WERE IDENTIFIED IN THE UNIT PACKAGING. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES.

    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. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC FOREIGN MATTER ON NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TECH WENT TO INSERT THE DEVICE AND NOTICED THAT THERE WAS A SMALL PIECE OF HARD PLASTIC ON THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742812 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4155276 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown