BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD WINGED BL 22GA X 1.0IN

    MDR report key: 11868020 · Received May 22, 2021

    Report

    Report Number
    1710034-2021-00432
    Event Type
    Malfunction
    Date Received
    May 22, 2021
    Date of Event
    April 13, 2021
    Report Date
    July 8, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-05-17. INVESTIGATION SUMMARY: BD RECEIVED A 22 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNIT FROM LOT 0191468 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 A CRACK ON THE CATHETER ADAPTER, JUST BELOW THE PUSH TAB. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT THAT OCCURRED DUE TO A MISALIGNMENT BETWEEN THE ADAPTER AND THE MANUFACTURING EQUIPMENT. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A NOTIFICATION WAS ISSUED BY THE MANUFACTURING FACILITY TO RAISE AWARENESS OF THIS INCIDENT AND PREVENT RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A INSYTE AUTOGUARD WINGED BL 22GA X 1.0IN WAS FOUND TO BE BROKEN AT THE CATHETER ADAPTOR BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CATHETER HAD JUST BEEN ASSEMBLED AND AFTER CONNECTING THE TUBING, THE NURSE NOTICED THAT THE CATHLON WAS BROKEN. THE CONSEQUENCES FOR THE PATIENT AND THE NURSING STAFF WERE THE ANXIETY GENERATED BY THE INCIDENT AND THE LOSS OF TIME CAUSED. THE PATIENT WAS REPERFUSED. WE HAVE A DEFECTIVE DM TO REPORT: IT IS A CATHLON REF (B)(4), 22 GA * 1.00 IN, 0.9*25MM. THE BASE IS BROKEN AT THE LEVEL OF THE WINGS."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A INSYTE AUTOGUARD WINGED BL 22GA X 1.0IN WAS FOUND TO BE BROKEN AT THE CATHETER ADAPTOR BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CATHETER HAD JUST BEEN ASSEMBLED AND AFTER CONNECTING THE TUBING, THE NURSE NOTICED THAT THE CATHLON WAS BROKEN. THE CONSEQUENCES FOR THE PATIENT AND THE NURSING STAFF WERE THE ANXIETY GENERATED BY THE INCIDENT AND THE LOSS OF TIME CAUSED. THE PATIENT WAS REPERFUSED. WE HAVE A DEFECTIVE DM TO REPORT: IT IS A CATHLON REF 381923, 22 GA * 1.00 IN, 0.9*25MM. THE BASE IS BROKEN AT THE LEVEL OF THE WINGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764751 INSYTE AUTOGUARD WINGED BL 22GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0191468

    Patients

    Seq Age Sex Outcome Treatment
    1