BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC GLOBAL

    MDR report key: 21270137 · Received January 29, 2025

    Report

    Report Number
    1710034-2025-00094
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    October 31, 2024
    Report Date
    March 18, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810444
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF A NEEDLE RETRACTION PROBLEM WAS CONFIRMED, AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. ONE 18G INSYTE AUTOGUARD SAMPLE FROM LOT #4152470 WAS PROVIDED FOR INVESTIGATION. THE SAMPLE WAS RECEIVED WITH THE SAFETY MECHANISM ACTIVATED. THE NEEDLE TIP WAS STUCK IN THE CATHETER ADAPTER. THE POSITION OF THE NOTCH IN THE NEEDLE APPEARED TO COINCIDE WITH THE SEPTUM. THE NOTCH AND NEEDLE WERE WITHIN SPECIFICATION. THE COMPLAINT APPEARED TO BE MANUFACTURING RELATED AND THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. 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 AUTOG BC GLOBAL NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: I AM TAKING THE LIBERTY OF CONTACTING YOU BECAUSE THE MATERNITY DEPARTMENT CONTACTED US ON (B)(6)2024 TO INFORM US OF A PROBLEM WHEN USING REFERENCE: (B)(4) / LOT: 4152470 / EXP: 31.05.2027. ¿CATHETER CANULA DOES NOT RETRACT. OBLIGED TO DEPERFUSE THE PATIENT TO REMOVE THE CANULA, EVEN MANUALLY IT DOESN'T COME OUT¿. THIS HAPPENED SEVERAL TIMES WITH DIFFERENT IDES AND DIFFERENT PATIENTS. THE DEVICES WERE DISCARDED, BUT I TESTED A CATHETER AND IT DIDN'T RETRACT PROPERLY, AND I STILL HAVE IT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682687 BD INSYTE AUTOG BC GLOBAL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4152470 00382903810444

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown