BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 17149491 · Received June 18, 2023

    Report

    Report Number
    1710034-2023-00696
    Event Type
    Malfunction
    Date Received
    June 18, 2023
    Date of Event
    May 23, 2023
    Report Date
    July 6, 2023
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 13-JUN-2023. H6) INVESTIGATION SUMMARY: BD RECEIVED FOUR SEALED 22 GAUGE INSYTE AUTOGUARD BLOOD CONTROL PRO WINGED UNITS FROM LOT 2192127 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING INSPECTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED FADED OR MISSING PRINT ON THE LEFT SIDE OF THE LABELS. THEREFORE, BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT THAT OCCURRED DURING THE PACKAGING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 4 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE PRINTING ON THE DEVICE LABEL WAS UNCLEAR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT UNCLEAR PRINTING ON PACKAGE. ACCORDING TO THE CUSTOMER'S REPORT, PRINTING ON PACKAGE IS UNCLEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 4 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE PRINTING ON THE DEVICE LABEL WAS UNCLEAR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT UNCLEAR PRINTING ON PACKAGE. ACCORDING TO THE CUSTOMER'S REPORT, PRINTING ON PACKAGE IS UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057934 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2192127

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown