BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 19575365 · Received June 20, 2024

    Report

    Report Number
    1710034-2024-00626
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    May 27, 2024
    Report Date
    October 18, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 382523 AND LOT NUMBER 4030767. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE REPORTED COMPLAINTS OF A DEFECTIVE CATHETER AND NEEDLE PUNCTURE DAMAGE COULD NOT BE CONFIRMED FROM THE RETURNED 22G INSYTE AUTOGUARD UNITS. NO DAMAGE OR DEFECTS ASSOCIATED WITH THE MANUFACTURING PROCESS COULD BE IDENTIFIED ON THE RETURNED SAMPLES. 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. MANUFACTURING CONTROLS ARE IN PLACE TO MITIGATE THE REPORTED ISSUE. THE INSERTION TECHNIQUE AND ANGLE COULD BE POTENTIAL CONTRIBUTING FACTORS OF THE REPORTED EVENT. THE INSTRUCTIONS FOR USE (IFU) ALSO INDICATE THAT THE NEEDLE SHOULD NOT BE REINSERTED INTO THE CATHETER DURING THE INSERTION PROCESS AS CATHETER DAMAGE MAY OCCUR. 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.

    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

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE PIERCED THE CATHETER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN HAVING A LOT OF TROUBLE WITH THE LAST LOT OF 22G IV I ORDERED. THEY SEEM FLIMSY AND THE NEEDLE IS GOING RIGHT THROUGH THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194092 BD INSYTE AUTOG BC PERIPHERAL IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030767 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown