BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20051832 · Received August 23, 2024

    Report

    Report Number
    1710034-2024-00926
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 30, 2024
    Report Date
    October 15, 2024
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. AN ADDITIONAL LOT NUMBER WAS PROVIDED IN THIS COMPLAINT FOR MATERIAL NUMBER 382533: LOT # 4093240. IT IS CAPTURED IN MFR REPORT # 1710034-2024-00910.

    Additional Manufacturer Narrative · 0

    BATCH NUMBER UPDATED IN D TAB. INVESTIGATION RESULTS: THE COMPLAINT OF A HOLD IN THE CATHETER COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 20GA INSYTE AUTOGUARD UNITS THAT WERE RECEIVED IN SEALED PACKAGING FROM LOT: 4093240. A FUNCTIONAL TEST REVEALED NO LEAKS IN THE UNUSED CATHETERS. THE AFFECTED UNIT WAS NOT PROVIDED FOR INVESTIGATION. ALTHOUGH THE REPRESENTATIVE SAMPLES AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC HAS A HOLE IN THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER HAS HOLE IN IT NEAR HUB (B)(6) 2024. 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO HARM WAS CAUSED TO PATIENT OR STAFF FOR THE CATHETERS THAT WERE IDENTIFIED WITH THE DEFECT. 2. WAS THERE ANY LEAK? YES, THAT IS HOW THE DEFECTIVE CATHETER WAS IDENTIFIED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380946 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4093240 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown