BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD GN 18GA X 1.16IN

    MDR report key: 11380357 · Received February 25, 2021

    Report

    Report Number
    1710034-2021-00150
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    January 29, 2021
    Report Date
    March 26, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814442
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED UNIT IN THREE PORTIONS: CATHETER TUBING, GREEN ADAPTER, AND NEEDLE/ HUB ASSEMBLY WITH THE NEEDLE FULLY RETRACTED WITHIN THE SAFETY BARREL. DURING THE VISUAL/MICROSCOPIC EXAMINATION IT WAS OBSERVED THAT THE CATHETER WEDGE APPEARED TO HAVE BACKED OUT OF THE ADAPTER, CONFIRMING YOUR REPORTED DEFECT. NO APPARENT DAMAGE TO THE WEDGE OR TUBING WAS NOTED. THIS DEFECT HAS BEEN LINKED TO THE MANUFACTURING PROCESS AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO ADDRESS THE ISSUE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOGUARD GN 18GA X 1.16IN CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 381444 BATCH, NO. 9212030. IT WAS REPORTED THAT CATHETER BROKE OFF RIGHT AFTER THE IV WAS INSERTED AND THE NEEDLE WAS RETRACTED. VERBATIM: CATHETER BROKE OFF RIGHT AFTER THE IV WAS INSERTED AND THE NEEDLE WAS RETRACTED. NO PATIENT HARM. NURSE WAS ABLE TO REMOVE THE CATHETER AND MADE SURE IT WAS INTACT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE AUTOGUARD GN 18GA X 1.16IN CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 381444, BATCH NO. 9212030. IT WAS REPORTED THAT CATHETER BROKE OFF RIGHT AFTER THE IV WAS INSERTED AND THE NEEDLE WAS RETRACTED. VERBATIM: CATHETER BROKE OFF RIGHT AFTER THE IV WAS INSERTED AND THE NEEDLE WAS RETRACTED. NO PATIENT HARM. NURSE WAS ABLE TO REMOVE THE CATHETER AND MADE SURE IT WAS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278880 INSYTE AUTOGUARD GN 18GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9212030 00382903814442

    Patients

    Seq Age Sex Outcome Treatment
    1