BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC

    MDR report key: 19505009 · Received June 10, 2024

    Report

    Report Number
    1710034-2024-00544
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    May 15, 2024
    Report Date
    July 24, 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
    NY, 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION FINDINGS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 217 SEALED 22GX1.00IN INSYTE AUTOGUARD DEVICES FROM LOT NUMBER: 4030768. A GROSS VISUAL INSPECTION OF ALL THE UNITS SHOWED THAT THEY ARE SEALED IN THE PACKAGING AND DO NOT HAVE PHYSICAL DAMAGE. NO DAMAGE WAS OBSERVED ON THE UNUSED CATHETERS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A FUNCTIONAL TEST WAS COMPLETED TO MEASURE THE NEEDLE TIP PENETRATION FORCE AND CATHETER TIP PENETRATION FORCE. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD BC CATHETER SPLITS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE SEEING THAT THE IV CATHETERS SPLIT WHILE NURSES ARE USING THEM ON PATIENTS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7779 BD INSYTE AUTOGUARD BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030768 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown