BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PERIPHERAL IV CATHETER INSYTE¿ AUTOGUARD¿

    MDR report key: 15580938 · Received October 11, 2022

    Report

    Report Number
    1710034-2022-00590
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 19, 2022
    Report Date
    December 8, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814336
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 13-OCT-2022. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE SEALED 20G X 1.00IN. INSYTE AUTOGUARD UNIT FROM LOT NUMBER 2192123. ADDITIONALLY, TWO PHOTOS WERE PROVIDED FOR INVESTIGATION. A GROSS VISUAL INSPECTION FOUND THAT A BLACK SPECK OF FOREIGN MATERIAL (FM) WAS LOOSE INSIDE THE PACKAGING. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED, AND THE CAUSE APPEARED TO BE RELATED TO THE PACKAGING PROCESS DURING MANUFACTURING. THE MATERIAL FOUND WAS LIKELY POLYETHYLENE, WHICH IS USED IN THE PACKAGING MATERIAL. 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 THE BD PERIPHERAL IV CATHETER INSYTE¿ AUTOGUARD¿ EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAS A BLACK SPECK IN THE PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PERIPHERAL IV CATHETER INSYTE¿ AUTOGUARD¿ EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAS A BLACK SPECK IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351881 BD PERIPHERAL IV CATHETER INSYTE¿ AUTOGUARD¿ INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381433 2192123 00382903814336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown