BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 15442126 · Received September 16, 2022

    Report

    Report Number
    1710034-2022-00508
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    July 8, 2022
    Report Date
    October 5, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826124
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAREGIVER WAS PLACING AN IV AND WENT TO ADVANCE THE CATHETER, THE CATHETER WOULDN'T ADVANCE SO ATTEMPTED TO RETRACT THE CATHETER BUT THE RETRACT BUTTON WOULDN'T RETRACT THE CATHETER.  CAREGIVER PULLED THE CATHETER OFF THE NEEDLE HUB AND WAS ABLE TO REMOVE THE NEEDLE MANUALLY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAREGIVER WAS PLACING AN IV AND WENT TO ADVANCE THE CATHETER, THE CATHETER WOULDN'T ADVANCE SO ATTEMPTED TO RETRACT THE CATHETER BUT THE RETRACT BUTTON WOULDN'T RETRACT THE CATHETER.  CAREGIVER PULLED THE CATHETER OFF THE NEEDLE HUB AND WAS ABLE TO REMOVE THE NEEDLE MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466535 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382612 1111852 00382903826124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown