BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 17194171 · Received June 23, 2023

    Report

    Report Number
    1710034-2023-00721
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    May 24, 2023
    Report Date
    July 6, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 05-JUN-2023. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED 20G X 1.00IN. INSYTE AUTOGUARD BC UNIT FROM LOT NUMBER 3093662. A GROSS VISUAL INSPECTION OF THE RETURNED UNIT DID NOT IDENTIFY ANY DAMAGE TO THE COMPONENTS. THE USED UNIT WAS MICROSCOPICALLY INSPECTED FOR ANYTHING THAT COULD HAVE PREVIOUSLY PREVENTED RETRACTION IN THE USER ENVIRONMENT. NO ADHESIVE OR OTHER DAMAGE/DEFECTS COULD BE IDENTIFIED. ADDITIONALLY, THE USED UNIT WAS UN-RETRACTED AND THEN TESTED FOR RETRACTION. THE USED UNIT SUCCESSFULLY RETRACTED WITHOUT ISSUE. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN THE REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. E1. ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, (B)(6) WAS USED AS A PLACE HOLDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT. 3 OF 3 RELATED FILES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATES THE CATHETER WOULDN'T RETRACT (SAFETY).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT. 3 OF 3 RELATED FILES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATES THE CATHETER WOULDN'T RETRACT (SAFETY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000835 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382533 3068163 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown