BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 10963804 · Received December 7, 2020

    Report

    Report Number
    1710034-2020-00784
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    October 4, 2020
    Report Date
    January 20, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 12/3/2020. H.6. INVESTIGATION: BD RECEIVED 2,242 UNOPENED UNITS. PER BD POLICY, FORTY-FIVE UNITS WERE SELECTED AT RANDOM FOR TESTING. THE UNITS WERE TESTED FOR LEAKAGE BEYOND THE SEPTUM BUT NO LEAKAGE WAS OBSERVED. BD WAS UNABLE TO CONFIRM THE REPORTED DEFECT. IF THE SEPTUM IS ENGAGED WHEN THE CONNECTION IS MADE (OR BEFORE) BLOOD WILL FLOW THROUGH THE OPENED SEPTUM, AS NOTED IN THE IFU. THE IFU ALSO STATES THAT THE BLOOD CONTROL FEATURE IS NOT INTENDED FOR LONG TERM USE AND A SECURE CONNECTION SHOULD BE MADE WITHIN 10 SECONDS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER EXPERIENCED BLOOD LEAKAGE THROUGH THE BC VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO : 382523, BATCH NO: 0252150. BLOOD CONTROL SEPTUM NOT EFFECTIVELY CONTAINING BLOOD. ONCE IV STARTED, BLOOD SPEWS OUT OF HUB IMMEDIATELY RATHER THAN STAYING CONTAINED BEHIND THE SEPTUM.

    Additional Manufacturer Narrative · 1

    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¿ SHIELDED IV CATHETER EXPERIENCED BLOOD LEAKAGE THROUGH THE BC VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO :382523 BATCH NO: 0252150. BLOOD CONTROL SEPTUM NOT EFFECTIVELY CONTAINING BLOOD. ONCE IV STARTED, BLOOD SPEWS OUT OF HUB IMMEDIATELY RATHER THAN STAYING CONTAINED BEHIND THE SEPTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428684 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0252150 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1