BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 16251461 · Received January 26, 2023

    Report

    Report Number
    1710034-2023-00040
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 9, 2023
    Report Date
    March 7, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, 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: 30-JAN-2023. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNSEALED 18GA X 1.16IN. INSYTE AUTOGUARD BC UNIT FROM LOT NUMBER 2171961. ADDITIONALLY, ONE PHOTO IS PROVIDED. THE SAFETY MECHANISM WAS DEACTIVATED, AND A VISUAL INSPECTION AND FUNCTIONAL TEST REVEALED NOTHING REMARKABLE. THE NEEDLE RETRACTED SUCCESSFULLY WHEN THE SAFETY MECHANISM WAS ACTIVATED. THE RETURNED UNIT PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE IN THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WOULD NOT RETRACT AFTER PRESSING THE BUTTON. THIS OCCURRED WITH 2 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PUSHED BUTTON AND NEEDLE WOULD NOT RETRACT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE IN THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WOULD NOT RETRACT AFTER PRESSING THE BUTTON. THIS OCCURRED WITH 2 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PUSHED BUTTON AND NEEDLE WOULD NOT RETRACT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431065 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2171961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown