BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7982838

    MDR report key: 17136387 · Received June 15, 2023

    Report

    Report Number
    1710034-2023-00685
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 18, 2023
    Report Date
    May 22, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, NJ WAS USED AS A PLACE HOLDER. 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. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER EXPERIENCED (SHORT DESCRIPTION OF EVENT). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STARTED THE BUTTON WOULD NOT RETRACT NEEDLE HAD TO KEEP PRESSING IT. TOOK LIKE 4 TIMES TO GET THE NEEDLE TO RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839130 7982838 INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3017216 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown