BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD YEL 24GA X .75IN

    MDR report key: 12077057 · Received June 28, 2021

    Report

    Report Number
    1710034-2021-00531
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    May 28, 2021
    Report Date
    July 22, 2021
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 2021-06-08. H6: INVESTIGATION SUMMARY: BD RECEIVED A 24 GAUGE INSYTE AUTOGUARD IV CATHETER UNIT FROM LOT 0191501 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 THAT THE NOSE OF THE ADAPTER HAD BEEN DAMAGED. THERE WAS ALSO SCRATCHING PRESENT ALONG THE LENGTH OF THE ADAPTER. 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 DURING THE ASSEMBLY PROCESS. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A NOTIFICATION HAS BEEN ISSUED BY THE MANUFACTURING FACILITY TO ALL ASSEMBLY PERSONNEL TO RAISE AWARENESS OF THIS ISSUE AND PREVENT RECURRENCE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOGUARD YEL 24GA X .75IN CATHETER HUB WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A DAMAGED CATHETER HUB. ACCORDING TO THE CUSTOMER'S REPORT, WHEN CHECKING THE PRODUCT UPON UNPACKING, THE HCP FOUND THAT THE CATHETER HUB WAS DEFORMED LIKE MELTED.

    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 INSYTE AUTOGUARD YEL 24GA X .75IN CATHETER HUB WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A DAMAGED CATHETER HUB. ACCORDING TO THE CUSTOMER'S REPORT, WHEN CHECKING THE PRODUCT UPON UNPACKING, THE HCP FOUND THAT THE CATHETER HUB WAS DEFORMED LIKE MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973398 INSYTE AUTOGUARD YEL 24GA X .75IN INTRAVASCULAR CATHETER FOZ 381812 0191501 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1