BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC BLU 22GA X 1.0IN

    MDR report key: 12178854 · Received July 15, 2021

    Report

    Report Number
    1710034-2021-00582
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    May 12, 2021
    Report Date
    July 14, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER: BD WAS INITIALLY MADE AWARE OF THIS COMPLAINT ON (B)(6) 2021. AT THAT TIME, BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER, IT WAS EVALUATED AS A NON-REPORTABLE INCIDENT. ADDITIONAL INFORMATION WAS LATER RECEIVED ON (B)(6) 2021 THAT CHANGED THE REPORTABILITY DETERMINATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THIS COMPLAINT IS NOW CONSIDERED TO BE AN MDR REPORTABLE INCIDENT. INVESTIGATION SUMMARY: BD RECEIVED A 22 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNIT FROM LOT 1011718 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER MICROSCOPICALLY INSPECTED THE RETURNED UNIT AND OBSERVED THAT THE CATHETER WALL WAS DAMAGED APPROXIMATELY 2/3 OF THE WAY UP THE CATHETER. IT APPEARED THAT THE NEEDLE HAD PIERCED THROUGH THE CATHETER. THERE WERE ALSO TRACES OF DRIED MEDIA PRESENT IN THE CATHETER TUBING. BASED OFF THE MICROSCOPIC INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: UNFORTUNATELY, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE DEVICE APPEARED TO HAVE BEEN USED. RATIONALE: CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS AND CURRENTLY DO NOT INDICATE THE NEED FOR A FORMAL CORRECTIVE ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE AUTOG BC BLU 22GA X 1.0IN NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS BEEN USING OUR INYSTE AUTOGUARD BLOOD CONTROL IV CATHETERS (382523) FOR SOME TIME NOW AND RECENTLY WITH LOT#1011718 THEY HAVE BEEN NOTICING THE CATHETER KIND OF "CURLING" UP WHEN PLACING IT IN THE VEIN AND NOW ALLOWING ADEQUATE FLOW TO HAPPEN." FROM INVESTIGATION: "OUR QUALITY ENGINEER MICROSCOPICALLY INSPECTED THE RETURNED UNIT AND OBSERVED THAT THE CATHETER WALL WAS DAMAGED APPROXIMATELY 2/3 OF THE WAY UP THE CATHETER. IT APPEARED THAT THE NEEDLE HAD PIERCED THROUGH THE CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074375 INSYTE AUTOG BC BLU 22GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1011718 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1