BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD-N STRAIGHT, 24G X 0.56"

    MDR report key: 15407427 · Received September 12, 2022

    Report

    Report Number
    1710034-2022-00493
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    August 11, 2022
    Report Date
    November 3, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814114
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 EVALUTION?: YES. D10: RETURNED TO MANUFACTURER ON: 12-SEP-2022 H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED A TOTAL OF 65 INSYTE AUTOGUARD UNITS FROM LOT NUMBER 1200239. OF THE 65 UNITS, TWO UNITS WERE UNSEALED IN THEIR PACKAGING. THROUGH THE INITIAL INSPECTION OF THE OPENED UNITS, ONE DISPLAYS A BENT NEEDLE (UNIT 1) AND THE OTHER UNIT A RETRACTION (UNIT 2) IS OBSERVED. THE REMAINING 63 REPRESENTATIVE UNITS HAD NO APPARENT DAMAGE. FURTHER INSPECTION OF UNIT 1 FOUND THAT THE NEEDLE HAS BENT NINETY DEGREES IN THE MIDDLE AND SLIGHTLY AT THE NOTCH AND THE NEEDLE COVER HAS BEEN SCRATCH MULTIPLE TIMES. THE NINETY-DEGREE BEND, THE BEND AT THE NOTCH AND SCRATCHES TO THE NEEDLE COVER ARE RESULTS OF THE NEEDLE CONTACTING THE NEEDLE COVER DURING PLACEMENT IN THE MANUFACTURING PROCESS. EVALUATION AND GROSS VISUAL INSPECTION OF THE UNIT 2 SHOWS AN OPENED PACKAGE WITH A SPRING AND NEEDLE THAT WERE FULLY RETRACTED. UPON REMOVING THE NEEDLE COVER, THE CATHETER ADAPTER STAYED INSIDE THE NEEDLE COVER. THE REPORTED ISSUE WAS CONFIRMED AS THE CATHETER RELEASED PREMATURELY. THIS TYPE OF DAMAGE SUGGESTS THAT HIGH FORCE WAS PRESENT WHEN THE CATHETER WAS LODGED INTO THE NEEDLE COVER WHICH IS MORE LIKELY TO OCCUR IN THE MANUFACTURING ENVIRONMENT. A 100% LIE DISTANCE TEST IS PERFORMED AND A MISORIENTED CATHETER SHOULD HAVE BEEN REJECTED BY THE VISION SYSTEM. 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 WHILE USING BD INSYTE AUTOGUARD-N STRAIGHT, 24G X 0.56" THE CATHETER SEPARATED FROM THE HUB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ENTIRE CATHETER CAME OFF WHEN THE TOP CAP WAS REMOVED LEAVING AN EXPOSED NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD-N STRAIGHT, 24G X 0.56" THE CATHETER SEPARATED FROM THE HUB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ENTIRE CATHETER CAME OFF WHEN THE TOP CAP WAS REMOVED LEAVING AN EXPOSED NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591704 BD INSYTE AUTOGUARD-N STRAIGHT, 24G X 0.56" INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381411 1200239 00382903814114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown