BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAG BC PRO GLOBAL GRN 18GA X 1.16IN

    MDR report key: 11980885 · Received June 11, 2021

    Report

    Report Number
    1710034-2021-00488
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 13, 2021
    Report Date
    July 21, 2021
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED TWO 18 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNITS FROM LOT 0210324 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 THERE WAS A PIECE OF CLEAR MATERIAL PRESENT ON THE TIP OF THE CATHETER WITH THE FIRST UNIT. NEXT, A MICROSCOPIC INSPECTION WAS PERFORMED ON BOTH UNITS. THE INSPECTION DETERMINED THAT THERE WAS NO FOREIGN MATTER (FM) PRESENT ON THE SECOND UNIT. THE PIECE OF CLEAR MATERIAL WAS COLLECTED AND IDENTIFIED AS SILICONE. SILICONE IS USED DURING THE MANUFACTURING PROCESS TO ASSIST WITH ASSEMBLY AND ENABLE A SMOOTH RETRACTION DURING USE. BASED OFF THE VISUAL AND MICROSCOPIC INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THE SILICONE CAME FROM THE MANUFACTURING PROCESS. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IAG BC PRO GLOBAL GRN 18GA X 1.16IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER ON THE CATHETER.

    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 IAG BC PRO GLOBAL GRN 18GA X 1.16IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883223 IAG BC PRO GLOBAL GRN 18GA X 1.16IN INTRAVASCULAR CATHETER FOZ 0210324

    Patients

    Seq Age Sex Outcome Treatment
    1