BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 18GA 1.25IN HF Y

    MDR report key: 12242436 · Received July 28, 2021

    Report

    Report Number
    1710034-2021-00629
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    June 29, 2021
    Report Date
    August 26, 2021
    Product Code
    FOZ
    UDI-DI
    00382903835393
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: 2021-08-11. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE DEVICE SUBMITTED FOR EVALUATION. BD RECEIVED ONE OPENED DEVICE. FUNCTIONAL TESTING OF THE DEVICE WAS UNABLE TO IDENTIFY ANY LEAKS OR OTHER NON-CONFORMANCES. SIMILARLY VISUAL INSPECTION OF THE DEVICE DISPLAYED NO OBSERVABLE DAMAGE TO THE UNIT. THE REPORTED ISSUE COULD NOT BE CONFIRMED AT THE CONCLUSION OF OUR REVIEW. THIS IS THE ONLY KNOWN OCCURRENCE OF THIS ISSUE BEING REPORTED FOR THIS MANUFACTURING LOT, AND A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. UNFORTUNATELY, THE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEXIVA 18GA 1.25IN HF Y LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ADMINISTRATION OF CONTRAST MEDIUM WITH 4ML/S, CONTRAST LEAKS THROUGH THE CAP WITH FILTER WHICH IS ON THE NEEDLE. THERE ARE 2 CAPS WITH FILTERS. FIRST I PUT THE ADMINISTRATION STROKE ON 1 CAP, THEN THE CONTRAST LEAKED ALONG THE ADMINISTRATION LINE. THEN PUT THE ADMINISTRATION LINE ON ANOTHER CAP. TESTED WITH SALT, WHERE THE SALT LEAKED OUT THROUGH CAP 1. SO THE FILTER OF THE CAP IS LEAKING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER EMAIL ADDRESS: (B)(6). 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 18GA 1.25IN HF Y LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ADMINISTRATION OF CONTRAST MEDIUM WITH 4ML/S, CONTRAST LEAKS THROUGH THE CAP WITH FILTER WHICH IS ON THE NEEDLE. THERE ARE 2 CAPS WITH FILTERS. FIRST I PUT THE ADMINISTRATION STROKE ON 1 CAP, THEN THE CONTRAST LEAKED ALONG THE ADMINISTRATION LINE. THEN PUT THE ADMINISTRATION LINE ON ANOTHER CAP. TESTED WITH SALT, WHERE THE SALT LEAKED OUT THROUGH CAP 1. SO THE FILTER OF THE CAP IS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137984 NEXIVA 18GA 1.25IN HF Y INTRAVASCULAR CATHETER FOZ 1011066 00382903835393

    Patients

    Seq Age Sex Outcome Treatment
    1