BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 17729663 · Received September 12, 2023

    Report

    Report Number
    1710034-2023-01045
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 28, 2023
    Report Date
    October 16, 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

    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. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE OF RETRACTION FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3110030. D4. MEDICAL DEVICE EXPIRATION DATE: 31JAN2026. H4. DEVICE MANUFACTURE DATE: 05MAY2023. D4. MEDICAL DEVICE LOT #: 3129615. D4. MEDICAL DEVICE EXPIRATION DATE: 30APR2026. H4. DEVICE MANUFACTURE DATE: 11MAY2023. D4. MEDICAL DEVICE LOT #: 3145629. D4. MEDICAL DEVICE EXPIRATION DATE: 30APR2026. H4. DEVICE MANUFACTURE DATE: 25MAY2023. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER IT WAS DIFFICULT TO ACTIVATE. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: PROBLEM INFORMATION NEEDLE WILL NOT RETRACT AT ALL OR WITH DIFFICULTY WHEN BUTTON PRESSED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER IT WAS DIFFICULT TO ACTIVATE. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: PROBLEM INFORMATION NEEDLE WILL NOT RETRACT AT ALL OR WITH DIFFICULTY WHEN BUTTON PRESSED. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801516 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown