BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 15635424 · Received October 19, 2022

    Report

    Report Number
    1710034-2022-00602
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    September 23, 2022
    Report Date
    December 2, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825449
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL?: YES. D9: RETURNED TO MANUFACTURER ON: 21-OCT-2022. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS PROVIDED FOR EVALUATION. BD RECEIVED ONE OPENED 18G X 1.16IN. INSYTE AUTOGUARD BC UNIT FROM LOT NUMBER 1182419. ADDITIONALLY, THREE PHOTOS WERE RECEIVED FOR INVESTIGATION. A GROSS VISUAL INSPECTION OF THE RETURNED UNIT FOUND THAT BLACK SPECKS OF FOREIGN MATERIAL (FM) WERE PRESENT ON THE GRIP. FURTHER INSPECTION UNDER A MICROSCOPE FOUND THAT THE FOREIGN MATTER WAS EMBEDDED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO THE MOLDING PROCESS. THE MATERIAL WAS DETERMINED TO BE BURNT PARTICULATE RESIN (NON-FOREIGN). THE BLACK SPECKS WERE MOST LIKELY CREATED AS PART OF THE MOLDING PROCESS. BURNT IMBEDDED RESIN SPECKS RESULT FROM MATERIAL BUILD UP IN THE BARREL/SCREW. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER EXPERIENCED FOREIGN MATTER ON THE DEVICE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER WAS FOUND WITH BLACK SPECKS IN THE MOLDING OF THE CATHETER & POSSIBLY ON THE INSIDE. WAS THE ISSUE DISCOVERED PRIOR TO USE? YES. WAS THERE ANY PATIENT HARM OR IMPACT? NO. WAS THERE ANY NEED FOR MEDICAL INTERVENTION OR TREATMENT DUE TO THE REPORTED ISSUE? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER EXPERIENCED FOREIGN MATTER ON THE DEVICE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER WAS FOUND WITH BLACK SPECKS IN THE MOLDING OF THE CATHETER & POSSIBLY ON THE INSIDE. WAS THE ISSUE DISCOVERED PRIOR TO USE? YES. WAS THERE ANY PATIENT HARM OR IMPACT? NO. WAS THERE ANY NEED FOR MEDICAL INTERVENTION OR TREATMENT DUE TO THE REPORTED ISSUE? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2176642 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382544 1182419 30382903825449

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown