BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN

    MDR report key: 12339385 · Received August 18, 2021

    Report

    Report Number
    1710034-2021-00721
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 20, 2021
    Report Date
    September 14, 2021
    Product Code
    FOZ
    UDI-DI
    00382903815111
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW FOR LOTS 0265143, 0080379, AND 9155710 SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. 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 INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT IV¿S THAT HAD GOOD BLOOD RETURN BLEW VEINS, ONE CATHETER WAS NOT INTACT WHEN TAKEN OUT OF THE PATIENT, AND FEELS LIKE THE SHEATH IS SHREDDING WHEN ADVANCED. DETAIL: AFTER 2 WEEKS OF USING THESE CATHETERS, THE THREE LOT NUMBERS WERE ASSOCIATED WITH HIGHER IV ATTEMPTS. THE STAFF REPORT THAT THE SHEATH DOES NOT ADVANCE EASILY OVER THE NEEDLE. THIS HAS RESULTED IN IV'S THAT HAD GOOD BLOOD RETURN, BLOWING WHEN FLUSHED. ONE CATHETER WAS NOT INTACT, WHEN TAKE OUT OF THE PATIENT. EXPERIENCED RNS, SAID "IT FEELS LIKE THE SHEATH IS SHREDDING WHEN I ADVANCE". NUMBER OF OCCURRENCES: 22.0.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 0265143. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2020-09-21. MEDICAL DEVICE LOT #: 0080379. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2020-03-24. MEDICAL DEVICE LOT #: 9155710. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2019-06-04. 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 INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT IV¿S THAT HAD GOOD BLOOD RETURN BLEW VEINS, ONE CATHETER WAS NOT INTACT WHEN TAKEN OUT OF THE PATIENT, AND FEELS LIKE THE SHEATH IS SHREDDING WHEN ADVANCED. DETAIL: AFTER 2 WEEKS OF USING THESE CATHETERS, THE THREE LOT NUMBERS WERE ASSOCIATED WITH HIGHER IV ATTEMPTS. THE STAFF REPORT THAT THE SHEATH DOES NOT ADVANCE EASILY OVER THE NEEDLE. THIS HAS RESULTED IN IV'S THAT HAD GOOD BLOOD RETURN, BLOWING WHEN FLUSHED. ONE CATHETER WAS NOT INTACT, WHEN TAKE OUT OF THE PATIENT. EXPERIENCED RNS, SAID "IT FEELS LIKE THE SHEATH IS SHREDDING WHEN I ADVANCE". NUMBER OF OCCURRENCES: 22.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237012 INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN INTRAVASCULAR CATHETER FOZ SEE H.10 00382903815111

    Patients

    Seq Age Sex Outcome Treatment
    1