BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ IV CATHETER

    MDR report key: 16687066 · Received April 5, 2023

    Report

    Report Number
    1710034-2023-00373
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 16, 2023
    Report Date
    May 19, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNSEALED 24GA X 0.75IN. INSYTE AUTOGUARD WINGED UNIT FROM LOT NUMBER 2192122. ADDITIONALLY, 8 PHOTOS WERE PROVIDED. THROUGH THE VISUAL INSPECTION, MEDIA WAS PRESENT IN THE DEVICE AND THE NEEDLE WAS PARTIALLY RETRACTED BUT THE TIP OF THE NEEDLE WAS STILL STICKING OUT. THE NEEDLE WAS PLACED BACK INTO ITS INITIAL POSITION TO TRY TO REPLICATE THE REPORT. THE NEEDLE DISPLAYED A DELAY DURING RETRACTION AND CONTINUED TO STOP IN THE SAME LOCATION WITH THE NEEDLE SLIGHTLY STICKING OUT. THE REPORTED ISSUE WAS CONFIRMED. FURTHER MICROSCOPIC ANALYSIS DISCOVERED THAT THERE WAS SOME DAMAGE TO THE NEEDLE HUB THAT WAS INTERFERING WITH THE COILS AND WITH THE RETRACTION PROCESS. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO A MACHINE MISALIGNMENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: 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¿ AUTOGUARD¿ IV CATHETER EXPERIENCED NEEDLE PARTIALLY RETRACTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT INCOMPLETE RETRACTION OF THE NEEDLE. ACCORDING TO THE CUSTOMER'S REPORT, AFTER CATHETER PLACEMENT, THE HCP ACTIVATED THE SAFETY MECHANISM,BUT THE NEEDLE STOPPED WITH ITS TIP SLIGHTLY PROTRUDING (APPROXIMATELY 1CM ) OUTSIDE THE SAFETY BARREL. THE NEEDLE WAS NOT RETRACTED COMPLETELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER EXPERIENCED NEEDLE PARTIALLY RETRACTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT INCOMPLETE RETRACTION OF THE NEEDLE. ACCORDING TO THE CUSTOMER'S REPORT, AFTER CATHETER PLACEMENT, THE HCP ACTIVATED THE SAFETY MECHANISM,BUT THE NEEDLE STOPPED WITH ITS TIP SLIGHTLY PROTRUDING (APPROXIMATELY 1CM ) OUTSIDE THE SAFETY BARREL. THE NEEDLE WAS NOT RETRACTED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912411 BD INSYTE¿ AUTOGUARD¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2192122

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown