BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 21565213 · Received March 10, 2025

    Report

    Report Number
    1710034-2025-00381
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 21, 2025
    Report Date
    March 26, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382533 AND LOT NUMBER 4242435. 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. BASED ON THE AVAILABLE INFORMATION, 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 AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INJURIES OR ADVERSE EVENT: NO. THE NEEDLE IS SUPPOSED TO RETRACT WITH THE PUSH OF A BUTTON, AND IT SOMETIMES EITHER DOESN'T RETRACT OR ONLY PARTIALLY RETRACTS, WHICH CAN BE DANGEROUS. WE'VE HAD THE PROBLEM WITH 2 DIFFERENT LOT NUMBERS. I DID CHECK THE RECALL LIST AS I KNEW THERE WAS A RECALL, BUT IT WAS FOR A DIFFERENT PROBLEM AND DIFFERENT LOT NUMBER. 2/26/2025: THE PROBLEM WAS NOTICED ON (B)(6) 2025, AND AGAIN ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986529 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4242435 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown