BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC PRO WINGED IV CATHETER

    MDR report key: 16935313 · Received May 15, 2023

    Report

    Report Number
    1710034-2023-00517
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    April 24, 2023
    Report Date
    June 21, 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

    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

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNSEALED 22GA X 1.00IN. INSYTE AUTOGUARD BC PRO WINGED UNIT FROM LOT NUMBER 2192127. ADDITIONALLY, (B)(4) PHOTOS WERE PROVIDED. THROUGH THE VISUAL INSPECTION THE BUTTON WAS FULLY ACTIVATED, BUT THE NEEDLE HUB WAS NOT RETRACTING. IT WAS THEN DISCOVERED THAT THE NEEDLE HUB HAD SOME DAMAGE THAT WAS PREVENTING THE NEEDLE HUB FROM RETRACTING. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT. A STATION MISALIGNMENT MAY CAUSE THE ADHESIVE TO POUR ON THE OUTSIDE OF THE HUB WHICH CAN THEN FLOW IN BETWEEN THE NEEDLE HUB AND THE GRIP OR THE BUTTON. THIS MAY CAUSE PARTIAL, SLOW OR NO RETRACTION. A VISION SYSTEM SOFTWARE IS IN PLACE TO MITIGATE THE OCCURRENCE OF THIS DEFECT. ANOTHER POSSIBILITY DURING MANUFACTURING IS DURING HUB LOADING, MACHINE MISALIGNMENT MAY CAUSE A DAMAGED HUB. THIS MAY CAUSE PARTIAL, SLOW OR NO RETRACTION. A FUNCTIONAL CHECK SAMPLING AS PER QUALITY CONTROL PLAN IS PERFORMED 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. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO WINGED IV CATHETER EXPERIENCED NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A NEEDLE RETRACTION FAILURE OF IAGBC. ACCORDING TO THE CUSTOMER'S REPORT, AFTER USE, THE HCP PRESSED THE BUTTON TO RETRACT THE NEEDLE; HOWEVER, THE NEEDLE WAS NOT RETRACTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO WINGED IV CATHETER EXPERIENCED NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A NEEDLE RETRACTION FAILURE OF IAGBC. ACCORDING TO THE CUSTOMER'S REPORT, AFTER USE, THE HCP PRESSED THE BUTTON TO RETRACT THE NEEDLE; HOWEVER, THE NEEDLE WAS NOT RETRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468092 BD INSYTE¿ AUTOGUARD¿ BC PRO WINGED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2192127

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown