BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD BC

    MDR report key: 8782231 · Received July 11, 2019

    Report

    Report Number
    1710034-2019-00760
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 26, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD RECEIVED A USED 20 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNIT FROM LOT 8120660 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 UNIT AND OBSERVED POROUS PLUG SHAVINGS AT THE TIP OF THE CATHETER TUBING. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. THE PLUG SHAVINGS WERE DETERMINED TO HAVE COME FROM THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD BC EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER IN THE CATHETER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD BC EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER IN THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576597 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8120660

    Patients

    Seq Age Sex Outcome Treatment
    1 Other