BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 20819530 · Received December 2, 2024

    Report

    Report Number
    1710034-2024-01408
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 15, 2024
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, THE REPORTED DEFECT OF NEEDLE RETRACTION FAILURE IS CONFIRMED SINCE A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE MODE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE. REGARDING ANOTHER REPORTED ISSUE OF NEEDLE RETRACTION SLOW, NO FINDINGS WERE FOUND IN CONFORMANCE'S REVIEW. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OF FA#.

    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE RETRACTED SLOWLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM NOW DEALING WITH 2 BAD LOTS FOR MATERIAL #381423. WE HAVE 3 MORE BOXES ON ORDER THAT SHOULD ARRIVE TOMORROW MORNING. LOT #S - 4241243 AND 4229661. 18 NOV COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? THE SAFETY MECHANISM DID NOT WORK ON SOME OF THE CATHETERS AND SOME OF THEM THE MECHANISM WAS DELAYED. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THERE WAS NOT PATIENT HARM, COMPLICATION, OR NEGATIVE OUTCOME. 26 NOV 4229661 IS THE ONLY LOT THAT IS AFFECTED. I TESTED 20 FROM THE OTHER LOT AND DID NOT ENCOUNTER AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97919 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4229661 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown