BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 22GA 1.00IN

    MDR report key: 15136128 · Received July 29, 2022

    Report

    Report Number
    1710034-2022-00405
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    June 30, 2022
    Report Date
    September 15, 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 AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL: YES. D.10. RETURNED TO MANUFACTURER ON: 14-JUL-2022. H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED THREE PHOTOGRAPHS AND ONE SEALED UNIT 22GA X 1.00IN INSYTE AUTOGUARD WINGED UNIT FROM LOT NUMBER 1172714. THROUGH THE VISUAL INSPECTION, BLACK FOREIGN MATTER WAS OBSERVED ON THE NEEDLE COVER. FURTHER MICROSCOPIC ANALYSIS DETERMINED IT WAS A LOOSE GRAINY BLACK MATTER. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT. THIS LOOSE FOREIGN MATERIAL MAY HAVE BEEN INTRODUCED DURING PACKAGING OR MANUFACTURING AS A RESULT OF ENVIRONMENTAL FACTORS, INCOMING MATERIAL, OR PERSONNEL. TO MITIGATE THE OCCURRENCE OF THESE DEFECTS: OPERATORS PERFORM CLEANING PER THE QUALITY PLAN, GOOD MANUFACTURING PRACTICES AND GOWNING ARE FOLLOWED, AND ENVIRONMENTAL CONTROLS AND INSPECTIONS FOR FOREIGN MATTER ARE PERFORMED PER THE QUALITY CONTROL AND SAMPLING PLANS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE TOP WEB LABEL WAS NOT RETURNED FOR EVALUATION. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 22GA 1.00IN FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT DIRT ON THE CAP OF IAG. ACCORDING TO THE CUSTOMER'S REPORT, BLACK DIRT ON THE CAP WAS FOUND BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 22GA 1.00IN FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT DIRT ON THE CAP OF IAG. ACCORDING TO THE CUSTOMER'S REPORT, BLACK DIRT ON THE CAP WAS FOUND BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411895 BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 22GA 1.00IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1172714

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown