BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ IV CATHETER

    MDR report key: 16970516 · Received May 20, 2023

    Report

    Report Number
    1710034-2023-00542
    Event Type
    Malfunction
    Date Received
    May 20, 2023
    Date of Event
    April 17, 2023
    Report Date
    July 2, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815112
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. 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 WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?YES. D10: RETURNED TO MANUFACTURER ON: 17-MAY-2023 H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE CATHETER ADAPTER OF A 24GX0.56IN INSYTE AUTOGUARD DEVICE FROM LOT NUMBER 3002689. THE CATHETER ADAPTER WAS TESTED FOR LEAKAGE WHERE LEAKAGE OCCURRED FROM UNDER THE NOSE OF THE YELLOW ADAPTER. THE CATHETER ADAPTER WAS REMOVED FROM THE CATHETER WHERE IT WAS FOUND THAT THE CATHETER TUBING HAS BEEN PIERCED LEAVING A SHAPE OF THE HALF CIRCLE CUT IN THE TUBING. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO THE SWAGE PROCESS. WHEN THE TUBING IS PLACED OVER A PIN, IT MAY GET PINCHED OR NICKED. MISALIGNMENT MAY RESULT IN THE PIN PIERCING THE CATHETER TUBING ALSO. OPERATORS PERFORM SAMPLING FOR SWAGE DEPTH AND FLARE DEPTH PER THE QUALITY PLAN. ADDITIONALLY, PER THE QUALITY CONTROL PLAN, INSPECTIONS FOR DAMAGED ADAPTER/CATHETER TUBING ARE PERFORMED PERIODICALLY DURING THE MANUFACTURING PROCESS TO MITIGATE THE OCCURRENCE OF THIS DEFECT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER EXPERIENCED HOLE IN CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATE MORE THAN ONE HOLE ON THE CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER EXPERIENCED HOLE IN CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATE MORE THAN ONE HOLE ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511273 BD INSYTE¿ AUTOGUARD¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381511 3002689 30382903815112

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown