BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 22GA 1.00IN Y

    MDR report key: 12302959 · Received August 10, 2021

    Report

    Report Number
    1710034-2021-00689
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 12, 2021
    Report Date
    October 4, 2021
    Product Code
    FOZ
    UDI-DI
    00382903835324
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1082130; D4: MEDICAL DEVICE EXPIRATION DATE: 2024-02-29; H4: DEVICE MANUFACTURE DATE: 2021-03-29. H6: INVESTIGATION SUMMARY NO SAMPLES WERE RECEIVED FROM LOTS 1011111 AND 1035214. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. OUR QUALITY ENGINEER INSPECTED THE SAMPLES FROM LOT 1082130 SUBMITTED FOR EVALUATION. BD RECEIVED TWO UNITS WITHIN OPENED PACKAGING AND ONE WITHIN A SEALED PACKAGE. DURING THE VISUAL EXAMINATION, IT WAS OBSERVED THAT THE PROTECTIVE NEEDLE COVERS WERE MISSING FROM ALL THREE UNITS. THE DEFECT OF MISSING NEEDLE COVER WAS CONFIRMED AND THE ROOT CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. PREVENTATIVE MAINTENANCE AND QUALITY INSPECTIONS ARE PERFORMED AT REGULAR INTERVALS TO MITIGATE THE RISK FROM THIS TYPE OF DEFECT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEXIVA 22GA 1.00IN Y WAS MISSING THE CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED MISSING THE SAFETY CAP ON THE NEEDLE, MISSING THE CLAMP - (OTHER), NEEDLE STICK.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1011111. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. DEVICE MANUFACTURE DATE: 2021-01-11. MEDICAL DEVICE LOT #: 1035214. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2021-02-04. 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 NEXIVA 22GA 1.00IN Y WAS MISSING THE CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED MISSING THE SAFETY CAP ON THE NEEDLE, MISSING THE CLAMP - (OTHER), NEEDLE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198833 NEXIVA 22GA 1.00IN Y INTRAVASCULAR CATHETER FOZ SEE H.10 00382903835324

    Patients

    Seq Age Sex Outcome Treatment
    1