BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD-N WINGED CATHETER

    MDR report key: 15921371 · Received December 5, 2022

    Report

    Report Number
    1710034-2022-00749
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    October 12, 2022
    Report Date
    January 23, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    50382903815116
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FDA NOTIFIED: THE INITIAL REPORTER NOTIFIED THE FDA VIA UF/IMPORTER REPORT#: MW5113075. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST 2 BD INSYTE AUTOGUARD-N WINGED CATHETERS EXPERIENCED CATHETER SPLITTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ATTEMPTED TO START IV X 2 ATTEMPTS WITH INSYTE-N AUTOGUACD WINGED 24 GAUGE X 0.56IN CATHETER (YELLOW PACKAGING, WITH WINGS). HOWEVER, WHEN RN TRIED TO ADVANCE CATHETER, CATHETER TIP "SHREDDED," AND COULD NOT BE ADVANCED. THIS HAPPENED TWICE, AND PER NNP HAS ALSO HAPPENED RECENTLY AT PVH. NORMAL PROCESS OF IV START WAS FOLLOWED. NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST 2 BD INSYTE AUTOGUARD-N WINGED CATHETERS EXPERIENCED CATHETER SPLITTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ATTEMPTED TO START IV X 2 ATTEMPTS WITH INSYTE-N AUTOGUACD WINGED 24 GAUGE X 0.56IN CATHETER (YELLOW PACKAGING, WITH WINGS). HOWEVER, WHEN RN TRIED TO ADVANCE CATHETER, CATHETER TIP "SHREDDED," AND COULD NOT BE ADVANCED. THIS HAPPENED TWICE, AND PER NNP HAS ALSO HAPPENED RECENTLY AT PVH. NORMAL PROCESS OF IV START WAS FOLLOWED. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112589 BD INSYTE AUTOGUARD-N WINGED CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381511 2146599 50382903815116

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown