BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 15920756 · Received December 5, 2022

    Report

    Report Number
    1710034-2022-00745
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    November 10, 2022
    Report Date
    December 28, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL, YES. D10: RETURNED TO MANUFACTURER ON: 18-NOV-2022. BD RECEIVED AN OPENED 20 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNIT FROM LOT 2220955 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 VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED BLACK SPECKS EMBEDDED INTO THE NEEDLE COVER. THEREFORE, BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. THE BLACK SPECKS AND DISCOLORATION WERE MOST LIKELY CREATED AS PART OF THE MOLDING PROCESS. BURNT EMBEDDED RESIN SPECKS RESULT FROM MATERIAL BUILD UP IN THE BARREL/SCREW. AS THE MATERIAL FLOWS THROUGH THE BARREL/SCREW THE BUILDUP BREAKS FREE AND ENDS UP IN THE MOLD. MOLDS ARE BEING PURGED REGULARLY BETWEEN THE LOTS TO AVOID THE BUILDUP OF THE BURNT/LOOSE MATERIAL. HOWEVER, ONE LOT CAN SOMETIMES TAKE UP TO TEN DAYS TO PRODUCE AND LEAD TO THE CREATION OF THE REPORTED DEFECT. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A NOTIFICATION WAS ISSUED BY THE MANUFACTURING FACILITY TO ALL APPROPRIATE PERSONNEL INVOLVED IN PURGING THE MOLDS TO RAISE AWARENESS OF THIS ISSUE AND ENSURE THAT EACH MOLD IS BEING PURGED PROPERLY.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV CATHETER APPEARED TO BE CONTAMINATED IN THE PACKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV CATHETER APPEARED TO BE CONTAMINATED IN THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422569 BD INSYTE AUTOGUARD INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382533 2220955 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown