BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 10286939 · Received July 16, 2020

    Report

    Report Number
    1710034-2020-00459
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    May 8, 2020
    Report Date
    August 20, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED AN UNUSED 22 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNIT FROM LOT 9241830 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED THE NEEDLE COVER WAS BACKWARDS ON THE UNIT. THE RETRACTION BUTTON WAS DEPRESSED AND THE SPRING WAS STICKING OUT ABOVE THE HUB. THERE WAS NO ISSUES FOUND WITH THE NEEDLE ITSELF AND IT WAS FOUND SECURE IN THE HUB. THE HUB WAS RETURNED TO THE STANDARD POSITION AND THE BUTTON WAS LOCKED INTO PLACE PREVENTING RETRACTION. THE CATHETER ADAPTER WAS PLACED CAREFULLY OVER THE NEEDLE AND FOUND TO SIT HIGHER ON THE NEEDLE DUE TO INTERFERENCE WITH THE SPRING. THIS WOULD RESULT IN THE CATHETER TIP AND CANNULA HAVING A SHORT LIE DISTANCE. THERE IS AN INLINE INSPECTION FOR LIE DISTANCE JUST AFTER THE SET CATHETER OVER NEEDLE STAGE OF MANUFACTURING. THIS PART WOULD FAIL THE LIE DISTANCE INSPECTION AS RECEIVED. IN THE CASE THAT THE SPRING WAS SITTING ON THE OUTSIDE OF THE ADAPTER IT WOULD NOT AFFECT LIE DISTANCE. THE SPRING MAY END UP IN THE INCORRECT POSITION OR SHAPE DUE TO BEING OUT OF SPECIFICATION (LARGE DIAMETER) OR GETTING CAUGHT DURING THE SPRING WINDING PROCESS. IN-PROCESS OPERATOR CHECKS MEASURE THE DIMENSIONS DURING THE SPRING WINDING PROCESS. IN THE EVENT OF A BOUND SPRING THE FORCE OF THE SPRING IS TESTED AT THE SPRING CHECK STATION. SAMPLING IS PERFORMED THROUGHOUT THE MANUFACTURING PROCESS INSPECTING FOR BOUND OR DAMAGED SPRINGS. PREVENTATIVE MAINTENANCE WAS VERIFIED TO BE UP TO DATE ON BOTH THE ZONE THE DEFECT MAY OCCUR AND THE ZONE WHERE THE DEFECT MAY HAVE BEEN DETECTED. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE FAILURE MODE OF RETRACTION FAILURE H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER'S NEEDLE CATHETER ADAPTER/CONNECTOR/HUG- CRACKED/OR BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿WHEN REMOVING THE NEEDLE COVER BEFORE CATHETER PLACEMENT, A SPRING-LIKE COMPONENT WAS COMING OUT OF THE HUB NEARBY AREA. THIS DEFECTIVE PRODUCT WAS NOT USED FOR A PATIENT.¿

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER'S NEEDLE CATHETER ADAPTER/CONNECTOR/HUG- CRACKED/OR BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿WHEN REMOVING THE NEEDLE COVER BEFORE CATHETER PLACEMENT, A SPRING-LIKE COMPONENT WAS COMING OUT OF THE HUB NEARBY AREA. THIS DEFECTIVE PRODUCT WAS NOT USED FOR A PATIENT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751320 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9241830

    Patients

    Seq Age Sex Outcome Treatment
    1 Other