BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 19928013 · Received August 7, 2024

    Report

    Report Number
    1710034-2024-00839
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 5, 2024
    Report Date
    October 2, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 150 SAMPLES INSIDE THREE DISPENSER AND EIGHT LOOSE SAMPLES. THE LABELS ON THE DISPENSERS CONTAINED REFERENCE NUMBER 381423 AND LOT NUMBER 4070001. A RANDOM SAMPLING OF 20 SAMPLES WERE PULLED FROM THE RETURNED 158. A VISUAL INSPECTION WAS PERFORMED ON THE 20 SAMPLES. NO CRACKS IN THE ADAPTER, CUTS/SPLITTING OF THE CATHETER TUBING, AND DAMAGE TO THE LUER ADAPTER WERE OBSERVED IN ANY OF THE SAMPLES. A LEAK TEST WAS PERFORMED WHERE NO LEAKAGE WAS OBSERVED. 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-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    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 AUTOGUARD LEAKS AT THE HUB/INFUSION TUBING JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CATHETERS ARE LEAKING WHEN THE CUSTOMER TRIES TO USE THEM. ON (B)(6) 2024 LEAKING WAS TAKING PLACE WHERE INFUSION TUBING CONNECTS TO THE HUB OF THE CATHETER. WE HAVE SINCE PURCHASED THE INSYTE AUTOGUARD BC CATHETERS AND DO NOT HAVE THIS PROBLEM WITH THEM. WE ENDED UP USING 49 OF THE 200 CATHETERS PURCHASED BEFORE WE CALLED ABOUT FAULTY CATHETERS AND PURCHASED THE OTHER ONES. THERE WERE NO NEGATIVE OUTCOMES, ONLY PROLONGED TIMING OF INFUSIONS WITH MULTIPLE REMOVAL OF DRESSINGS AND RE-TIGHTENING THE INFUSION TUBING ONTO THE HUB OF THE CATHETER. PROBABLY HALF OF THE IV¿S WE USED WOULD LEAK FROM AROUND THE SITE THAT THE TUBING ATTACHED TO THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278012 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4070001 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown