BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16

    MDR report key: 15765045 · Received November 9, 2022

    Report

    Report Number
    1710034-2022-00671
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 17, 2022
    Report Date
    January 3, 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

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. 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: 22-NOV-2022 H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 50 SEALED 20GA X 1.16IN. INSYTE AUTOGUARD UNITS FROM NUMBER 2160587. A SAMPLING OF 20 UNITS WERE EXAMINED AND TESTED. OF THE 20 UNITS TESTED, 6 UNITS FAILED TO RETRACT. EACH FAILED UNIT WAS MICROSCOPICALLY ANALYZED, AND ADHESIVE WAS DISCOVERED BETWEEN THE BUTTON AND THE HUB. THIS PREVENTED THE BUTTON FROM BEING PRESSED WHICH CAUSED THE NEEDLE RETRACTION FAILURE. THE REPORTED ISSUE WAS CONFIRMED AND DETERMINED TO BE MANUFACTURING RELATED. DURING MANUFACTURING ADHESIVE IS DISPENSED INTO THE HUB TO SECURE THE CANNULA. A STATION ALIGNMENT MAY CAUSE ADHESIVE TO BE ON THE OUTSIDE OF THE HUB, CAUSING PARTIAL OR NO RETRACTION. A VISION SYSTEM SOFTWARE AND FUNCTIONAL TESTING PLAN IS PERFORMED TO MITIGATE THE OCCURRENCE OF THIS DEFECT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10

    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: PER CUSTOMER, 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: PER CUSTOMER, 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
    2954023 BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16 INTRAVASCUALR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381434 2160587 00382903814343

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown