BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER

    MDR report key: 17080107 · Received June 7, 2023

    Report

    Report Number
    1710034-2023-00632
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    May 15, 2023
    Report Date
    July 7, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903925230
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: "THE REPORTED PROBLEM WAS THE PLASTIC CATHETER LEFT IN THE PATIENT ARM WAS CRACKED AND STARTED LEAKING AS SOON AS THE NEEDLE WAS RETRACTED. WE HAVE PULLED THIS ENTIRE LOT OUT OF INVENTORY. PLEASE HELP WITH NEXT STEPS." H.6 IMDRF ANNEX A - MEDICAL DEVICE PROBLEM CODE: ADDED A CODE - A0504.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: "THE REPORTED PROBLEM WAS THE PLASTIC CATHETER LEFT IN THE PATIENT ARM WAS CRACKED AND STARTED LEAKING AS SOON AS THE NEEDLE WAS RETRACTED. WE HAVE PULLED THIS ENTIRE LOT OUT OF INVENTORY. PLEASE HELP WITH NEXT STEPS".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: "THE REPORTED PROBLEM WAS THE PLASTIC CATHETER LEFT IN THE PATIENT ARM WAS CRACKED AND STARTED LEAKING AS SOON AS THE NEEDLE WAS RETRACTED. WE HAVE PULLED THIS ENTIRE LOT OUT OF INVENTORY. PLEASE HELP WITH NEXT STEPS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER WAS NOT RETRACTING AFTER PLACEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: "NEEDLE NOT RETRACTING WHEN IV CATHETER PLACEMENT WAS COMPLETED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439846 BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 392523 2308068 00382903925230

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown