BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC YEL 24GA X 0.75IN

    MDR report key: 21741791 · Received April 1, 2025

    Report

    Report Number
    1710034-2025-00504
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    September 15, 2024
    Report Date
    April 25, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825127
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. YOUR REPORT OF A HOLE IN THE CATHETER WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. ONE 24G INSYTE AUTOGUARD IV CATHETER WAS RETURNED FOR INVESTIGATION. THE SAMPLE EXHIBITED EVIDENCE OF USE. A FUNCTIONAL TEST REVEALED A BREACH IN THE CATHETER TUBING; HOWEVER, DUE TO THE EVIDENCE OF USE, IT COULD NOT BE DETERMINED WHEN OR HOW THE CATHETER WAS DAMAGED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC YEL 24GA X 0.75IN CATHETER DEFECTIVE / DAMAGED   IT WAS REPORTED BY CUSTOMER THAT CATHETER HAS A HOLE NEAR THE TOP (BY THE HUB) NOTICED BLOOD BUBBLING FROM THE HOLE WHILE ATTEMPTING TO THREAD THE CATHETER INTO THE PATIENT.   VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO. ITEM: 382512 QUANTITY AFFECTED: 8 BX SERIAL/LOT NUMBER: (B)(6). PO : 4518267975 ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: XXXXXX REQUEST CREDIT FOR QUALITY ISSUE 8 BX B-(B)(4). LOT# 4116717 DATE OF INCIDENT: 9/15/24 ¿ NO PT. HARM PROBLEM: THE CATHETER HAS A HOLE NEAR THE TOP (BY THE HUB) NOTICED BLOOD BUBBLING FROM THE HOLE WHILE ATTEMPTING TO THREAD THE CATHETER INTO THE PATIENT. SAMPLE AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166136 BD INSYTE AUTOG BC YEL 24GA X 0.75IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4116717 00382903825127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown