BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8603567 · Received May 13, 2019

    Report

    Report Number
    1710034-2019-00516
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    April 25, 2019
    Report Date
    June 17, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED 43 INSYTE AUTOGUARD 24 GAUGE UNITS FROM LOT 8061879 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 PHYSICAL/MECHANICAL DAMAGE TO ANY OF THE UNITS. NEXT, A WATER/AIR LEAK TEST WAS PERFORMED FOR THE RETURNED UNITS AND NO LEAKAGE WAS OBSERVED COMING FROM THE UNITS. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER LEAKS BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381412, BATCH NO.: 8061879. IT WAS REPORTED THAT BLOOD DRIPS OUT OF THE CANNULA. VERBATIM: BLOOD DRIPS OUT OF THE CANNULA.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER LEAKS BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381412 BATCH NO.: 8061879. IT WAS REPORTED THAT BLOOD DRIPS OUT OF THE CANNULA. VERBATIM: BLOOD DRIPS OUT OF THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399440 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8061879 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other