BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 15790185 · Received November 14, 2022

    Report

    Report Number
    1710034-2022-00682
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 19, 2022
    Report Date
    February 14, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 06-JAN-2023. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2160587. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, FIVE UNITS WERE RETURNED TO OUR FACILITY TO AID IN INVESTIGATION AND TESTING EFFORTS. OF THE FIVE SAMPLES FOUR HAD BEEN SUCCESSFULLY RETRACTED. THE FIFTH DEVICE APPEARED TO BE UNUSED BUT WAS RETURNED IN AN OPENED PACKAGING UNIT. FUNCTIONAL TESTING OF THIS DEVICE WAS SUCCESSFUL IN RETRACTING THE NEEDLE AND ENGAGING THE SAFETY FEATURE. THE REPORTED NONCONFORMANCE COULD NOT BE CONFIRMED.

    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

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. 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 THAT THE NEEDLE IN THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER FAILED TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿THE AUTO GUARD CATH FAILED TO RETRACT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE IN THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER FAILED TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿THE AUTO GUARD CATH FAILED TO RETRACT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE IN THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER FAILED TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿THE AUTO GUARD CATH FAILED TO RETRACT.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1782834 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381434 2160587 00382903814343

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown