BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 22287262 · Received June 18, 2025

    Report

    Report Number
    1710034-2025-01046
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 15, 2025
    Report Date
    July 8, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE
    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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382544 AND LOT NUMBER 5010456. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN 18 G BD INSYTE IV ONGOING CONCERNS. TWO (2) NEEDLESTICKS HAVE OCCURRED, ONE IN (B)(6) 2024 AND ONE IN (B)(6) 2025. THERE HAVE BEEN SEVERAL NEAR MISSES. A LOT 5010456 WAS RETURNED IN MARCH WITH THESE CONCERNS REPORTED TO BD. PICTURE OF LOT RETURNED INCLUDED BELOW. (B)(6) ANOTHER NEAR MISS WAS REPORTED WITH LOT 5017998. SPEAKING WITH STAFF ON (B)(6) AND(B)(6) THEY HAVE HAD ONGOING DIFFICULTY ENGAGING SAFETY MECHANISM, NEEDLE SLOW TO RETRACT, GETTING STUCK HALFWAY IN CATHETER, OR NOT RETRACTING AT ALL. REF REPORT: MW5170601. ON TUE 06/17/2025 I HAVE PROVIDED ALL RELEVANT INFORMATION VARIOUS TIMES. THE ONLY NEW INFORMATION IS LOT NUMBERS WITH THE SAME PROBLEMS AS ALREADY REPORTED. PRIOR INJURIES WERE REPORTED AND THERE HAVE BEEN NO NEW INJURIES. IT¿S THE ONGOING FAILED SAFETY MECHANISM IN THE FOLLOWING WAYS - HARD TO PRESS BUTTON, NEEDLE SLOW TO RETRACT, NEEDLE GETS CAUGHT HALFWAY, OR NEEDLE DOES NOT RETRACT AT ALL. I ALREADY PROVIDED DATES OF OCCURRENCE AND LOT NUMBERS INVOLVED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747438 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5010456 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown