BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8951199 · Received August 30, 2019

    Report

    Report Number
    1710034-2019-00953
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 15, 2019
    Report Date
    September 26, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A 22 GAUGE INSYTE AUTOGUARD UNIT FROM LOT 9010578 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO RELATED QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED THAT THE NEEDLE WAS RETRACTED INTO THE SAFETY BARREL. THE NEEDLE WAS RESET AND EVALUATED. THERE WAS NO PHYSICAL/MECHANICAL DAMAGE OBSERVED. HOWEVER, THE CATHETER WAS FOUND TO BE LODGED INSIDE OF THE NEEDLE COVER AND MISORIENTED INSIDE. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THAT THERE WAS A MIS-ALIGNMENT WITH THE ADAPTER ASSEMBLY. IT WAS DETERMINED THAT THIS MISORIENTATION CAUSED THE RETRACTION AND PREVENTED THE CATHETER FROM BEING SEPARATED FROM THE NEEDLE COVER. HOWEVER, THE UNIT WAS OPENED, THEREFORE WE WERE UNABLE TO CONFIRM WHETHER THE COVER OR THE CATHETER/ADAPTER WERE MANIPULATED PRIOR TO USE (USER ENVIRONMENT) OR MIS-ASSEMBLED (MANUFACTURING).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 22G X1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD EXPERIENCED CATHETER DAMAGE/DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOFT NEEDLE UNEVENNESS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 22G X 1.00 IN (0.9 X 25 MM) INSYTE AUTOGUARD EXPERIENCED CATHETER DAMAGE/DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOFT NEEDLE UNEVENNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746397 22G X1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9010578 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other