BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22G X1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD

    MDR report key: 8894858 · Received August 14, 2019

    Report

    Report Number
    1710034-2019-00883
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    July 29, 2019
    Report Date
    September 4, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A 22 GAUGE INSYTE AUTOGUARD UNIT FROM LOT 9010577 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 A BROWN/BLACK STAIN ON THE GRIP OF THE UNIT AND SEVERAL BLACK SPECKS THROUGHOUT THE GRIP. THE STAIN/SPECKS WERE DETERMINED TO HAVE BEEN EMBEDDED INTO THE PLASTIC. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. THE STAIN/SPECKS WERE DETERMINED TO HAVE BEEN PIECES OF BURNT RESIDUAL MATERIAL CAUSED BY THE MOLDING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 22G X1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AROUND CATHETER ADAPTER WAS BLACK.

    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 22G X1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AROUND CATHETER ADAPTER WAS BLACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685524 22G X1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9010577 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other