BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 11269778 · Received February 2, 2021

    Report

    Report Number
    1710034-2021-00074
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Date of Event
    January 7, 2021
    Report Date
    June 16, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-02-17. H6: INVESTIGATION SUMMARY: BD RECEIVED TWO INSYTE AUTOGUARD BLOOD CONTROL UNITS FROM LOT 0252150 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED NO VISIBLE DAMAGE TO THE EITHER UNIT. NEXT, THE UNITS WERE TESTED FOR LEAKAGE BEYOND THE SEPTUM AND NO LEAKAGE OR DAMAGE WAS FOUND TO THE UNITS. FINALLY, THE UNITS WERE DISSECTED AND THE SEPTUMS WERE INSPECTED UNDER A MICROSCOPE. NO DAMAGE OR TEARING WAS FOUND TO EITHER UNIT. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE FOUND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER LEAKED BLOOD UNTIL CONNECTED TO THE IV. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DEVICE DID NOT HOLD THE BLOOD BACK UNTIL IT WAS HOOKED UP TO THE I.V. THIS HAPPENED 5 TIMES IN THE LAST FEW DAYS. BLOOD LEAKAGE UNTIL NURSE COULD CONNECT I.V."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER LEAKED BLOOD UNTIL CONNECTED TO THE IV. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DEVICE DID NOT HOLD THE BLOOD BACK UNTIL IT WAS HOOKED UP TO THE I.V. THIS HAPPENED 5 TIMES IN THE LAST FEW DAYS. BLOOD LEAKAGE UNTIL NURSE COULD CONNECT I.V."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161563 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 0252150 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1