BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16"

    MDR report key: 16301608 · Received February 4, 2023

    Report

    Report Number
    1710034-2023-00069
    Event Type
    Malfunction
    Date Received
    February 4, 2023
    Date of Event
    January 13, 2023
    Report Date
    March 8, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814343
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 30JAN2023. H6: INVESTIGATION SUMMARY: BD RECEIVED TEN SEALED 20 GAUGE INSYTE AUTOGUARD UNITS FROM LOT 2160587 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 VISIBLE DAMAGE OR DEFORMITIES TO THE UNITS OR THEIR COMPONENTS. NEXT, THE UNITS WERE TESTED FOR FUNCTIONAL RETRACTION AND EACH UNIT RETRACTED SUCCESSFULLY WITH NO RESISTANCE OR DELAY OBSERVED. THEREFORE, BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE FOUND DURING INSPECTION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THIS FAILURE MODE AND AN INVESTIGATION HAS BEEN LAUNCHED BY THE MANUFACTURING FACILITY TO CORRECT THIS ISSUE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16" THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD MULTIPLE CATHETERS, ALL FROM LOT#: 2160587, THAT DO NOT RETRACT THE NEEDLE WHEN THE BUTTON IS PRESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16" THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD MULTIPLE CATHETERS, ALL FROM LOT #2160587, THAT DO NOT RETRACT THE NEEDLE WHEN THE BUTTON IS PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82153 BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16" INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381434 2160587 00382903814343

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown