BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 15351257 · Received September 2, 2022

    Report

    Report Number
    1710034-2022-00471
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 8, 2022
    Report Date
    October 24, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825349
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1351797. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2024. DEVICE MANUFACTURE DATE: 17-DEC-2021. MEDICAL DEVICE LOT #: 2053116. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2025. DEVICE MANUFACTURE DATE: 22-FEB-2022. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 43 SEALED 20G X 1.16IN. INSYTE AUTOGUARD BC UNITS FROM LOT NUMBER 2053116. ALL RETURNED UNITS WERE VISUALLY INSPECTED FOR CATHETER DAMAGE AND LEAK TESTED. THE GROSS VISUAL INSPECTION DID NOT IDENTIFY ANY DAMAGE AND LEAK TESTING DID NOT IDENTIFY ANY LEAKS. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN THE REPORT. 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 AN UNSPECIFIED NUMBER OF BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS EXPERIENCED FRAYED CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHEERING AT THE END OF CATHETER IS REMAINING IN THE PATIENT. SEVERAL INCIDENTS THIS SITUATION HAS HAPPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS EXPERIENCED FRAYED CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHEERING AT THE END OF CATHETER IS REMAINING IN THE PATIENT. SEVERAL INCIDENTS THIS SITUATION HAS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2560328 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H10 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown