BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN

    MDR report key: 12173335 · Received July 15, 2021

    Report

    Report Number
    1710034-2021-00575
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    November 18, 2020
    Report Date
    August 16, 2021
    Product Code
    FOZ
    UDI-DI
    00382903815111
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 0195143, 0080379, AND 0119474 THERE WAS 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 CATHETER SPLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER SPLINTERS OR SPLITS, IS DIFFICULT TO PUNCTURE SKIN, AND DOES NOT THREAD RIGHT. MULTIPLE COMPLAINTS FROM NURSING STAFF OF BD INTRAVASCULAR CATHETERS SPLINTERING OR SPLITTING. UPON SINGLE ATTEMPT, THE PLASTIC SHEATH OF CATHETER SPLINTERS WHEN NEEDLE IS RE-INTRODUCED. ON INITIAL INSERTION, THERE HAVE BEEN COMPLAINTS OF NEEDLE NOT CANNULATING THE SKIN/VEIN EASILY AND RESISTANCE IS MET. IV INFILTRATES APPEAR TO BE TRENDING UP.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE 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 #: 0195143. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. DEVICE MANUFACTURE DATE: 2020-07-13. MEDICAL DEVICE LOT #: 0080379. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2020-03-24. MEDICAL DEVICE LOT #: 0119474. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2020-05-01. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 CATHETER SPLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER SPLINTERS OR SPLITS, IS DIFFICULT TO PUNCTURE SKIN, AND DOES NOT THREAD RIGHT. MULTIPLE COMPLAINTS FROM NURSING STAFF OF BD INTRAVASCULAR CATHETERS SPLINTERING OR SPLITTING. UPON SINGLE ATTEMPT, THE PLASTIC SHEATH OF CATHETER SPLINTERS WHEN NEEDLE IS RE-INTRODUCED. ON INITIAL INSERTION, THERE HAVE BEEN COMPLAINTS OF NEEDLE NOT CANNULATING THE SKIN/VEIN EASILY AND RESISTANCE IS MET. IV INFILTRATES APPEAR TO BE TRENDING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072392 INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN INTRAVASCULAR CATHETER FOZ SEE H.10 00382903815111

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR