BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 17083032 · Received June 7, 2023

    Report

    Report Number
    1710034-2023-00637
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    May 16, 2023
    Report Date
    June 12, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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

    H6: INVESTIGATION SUMMARY : 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE RETRACTION BUTTON IS STICKING ON THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER CUSTOMER: TWO OF OUR DOCTORS HAVE USED A CATHETER (333-381812) FROM LOT 2242830 AND HAVE EXPERIENCED THE SAME PROBLEM. THE NEEDLE RETRACTION BUTTON IS GETTING STUCK WHEN PUSHED AND THE NEEDLE IS NOT FULLY RETRACTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE RETRACTION BUTTON IS STICKING ON THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER CUSTOMER: TWO OF OUR DOCTORS HAVE USED A CATHETER (333-381812) FROM LOT 2242830 AND HAVE EXPERIENCED THE SAME PROBLEM. THE NEEDLE RETRACTION BUTTON IS GETTING STUCK WHEN PUSHED AND THE NEEDLE IS NOT FULLY RETRACTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439995 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381812 2242830 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown