BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTO-GUARD¿ SAFETY IV CATHETER

    MDR report key: 16513240 · Received March 9, 2023

    Report

    Report Number
    1710034-2023-00215
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 14, 2023
    Report Date
    April 13, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818440
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 2252129, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED AN 18 GAUGE INSYTE AUTOGUARD IV CATHETER OVER A NEEDLE. THE DEVICE APPEARED TO BE NEW AND UNUSED WITH BLACK FOREIGN MATTER (FM) EMBEDDED INTO THE GREEN CATHETER ADAPTER. THEREFORE, BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT. THE APPEARANCE OF THE MATERIAL PRESENT IN THE PHOTO WAS CONSISTENT WITH NON-FOREIGN MATTER THAT WAS INTRODUCED DURING THE MOLDING PROCESS. DURING MOLDING, RESIN WAS USED TO FORM THE DEVICE AND IT IS POSSIBLE THAT FLECKS OF BURNT RESIN WERE STILL PRESENT WHEN THE ADAPTER COMPONENT WAS MOLDED. BURNT EMBEDDED RESIN SPECKS RESULT FROM MATERIAL BUILD UP IN THE BARREL/SCREW THAT BREAKS FREE AND ENDS UP IN THE MOLD. MOLDS ARE BEING PURGED BETWEEN THE LOTS TO AVOID THE BUILDUP OF THE BURNT/LOOSE MATERIAL BUT EACH LOT CAN TAKE SEVERAL DAYS TO COMPLETE BEFORE THEY CAN BE PURGED. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A NOTIFICATION WAS ISSUED BY THE MANUFACTURING FACILITY TO ALL MANUFACTURING PERSONNEL INVOLVED IN THE MOLDING PROCESS TO RAISE AWARENESS OF THIS INCIDENT AND PREVENT RECURRENCE. 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTO-GUARD¿ SAFETY IV CATHETER BLACK FOREIGN MATTER WAS DISCOVERED IN THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: BLACK PARTICLES ARE OBSERVED INSIDE THE CATHETER BODY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTO-GUARD¿ SAFETY IV CATHETER BLACK FOREIGN MATTER WAS DISCOVERED IN THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: BLACK PARTICLES ARE OBSERVED INSIDE THE CATHETER BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140177 BD INSYTE¿ AUTO-GUARD¿ SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381844 2252129 00382903818440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown