BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 21439964 · Received February 21, 2025

    Report

    Report Number
    1710034-2025-00299
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 21, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810338
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381033 AND LOT NUMBER 4190490. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DATE OF OCCURRENCE: (B)(6) 2025. PLACE OF OCCURRENCE: EMERGENCY DEPARTMENT. CIRCUMSTANCES OF OCCURRENCE / DESCRIPTION OF FACTS: ABSENCE OF NEEDLE RETRACTION WHEN USING THE CATHETER. CLINICAL CONSEQUENCES OBSERVED: NONE - RISK OF AES (ACCIDENT EXPOSING TO BLOOD) FOR THE CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706915 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4190490 00382903810338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown