BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 13502291 · Received February 9, 2022

    Report

    Report Number
    1710034-2022-00068
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    January 28, 2022
    Report Date
    February 22, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    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 SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE OPENED RETRACTED INSYTE AUTOGUARD DEVICE FROM LOT NUMBER 1130375. IN ADDITION, FIVE PHOTOGRAPHS WERE SUBMITTED WHICH DID NOT DISPLAY ANY VISIBLE FOREIGN MATTER. THE RETURNED UNIT WAS INSPECTED FOR ANY SIGNS OF FOREIGN MATTER IN WHICH NONE WERE FOUND IN EITHER THE RETRACTED OR UN-RETRACTED POSITION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEAR THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE CUSTOMER REPORTED THAT AN FM WAS FOUND TO BE ADHERING NEAR THE NEEDLE (CATHETER)."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEAR THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE CUSTOMER REPORTED THAT AN FM WAS FOUND TO BE ADHERING NEAR THE NEEDLE (CATHETER)."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEAR THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THE CUSTOMER REPORTED THAT AN FM WAS FOUND TO BE ADHERING NEAR THE NEEDLE (CATHETER)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850415 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1130375

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown