BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 10171319 · Received June 18, 2020

    Report

    Report Number
    1710034-2020-00376
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 27, 2020
    Report Date
    July 6, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825333
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL FEATURE WOULD NOT WORK. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382533 BATCH NO: 9212068 IT WAS REPORTED THAT "THE BLOOD CAME BACK AGAIN". CONTACTED REP VIA EMAIL ON (B)(6) 2020 OF AN INSTANCE OF THE BD INSYTE AUTOGUARD BC 20G X 1" NEEDLE "WHERE THE BLOOD CONTROL IS NOT WORKING PROPERLY. " VERY LIMITED INFORMATION PERTAINING TO CLINICAL END USER, SEQUENCE OF EVENTS, INSERTION TECHNIQUE ETC. CUSTOMER COMMUNICATED THAT THE BLOOD CAME BACK AGAIN TODAY. I HAVE THE PACKAGING BUT NOT THE PRODUCT AS IT WAS CONTAMINATED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL FEATURE WOULD NOT WORK. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382533 BATCH NO: 9212068. IT WAS REPORTED THAT "THE BLOOD CAME BACK AGAIN". CONTACTED REP VIA EMAIL ON (B)(6) 2020 OF AN INSTANCE OF THE BD INSYTE AUTOGUARD BC 20G X 1" NEEDLE "WHERE THE BLOOD CONTROL IS NOT WORKING PROPERLY. " VERY LIMITED INFORMATION PERTAINING TO CLINICAL END USER, SEQUENCE OF EVENTS, INSERTION TECHNIQUE ETC. CUSTOMER COMMUNICATED THAT THE BLOOD CAME BACK AGAIN TODAY. I HAVE THE PACKAGING BUT NOT THE PRODUCT AS IT WAS CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635781 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382533 9212068 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other