BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 15499820 · Received September 28, 2022

    Report

    Report Number
    1710034-2022-00559
    Event Type
    Malfunction
    Date Received
    September 28, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 4, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825349
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE REPORTED LOT# 2153596 WAS NOT FOUND FOR THE REPORTED CATALOG# 382534. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. ILLINOIS, USA HAS BEEN USED AS A PLACEHOLDER BASED ON THE REPORTED PHONE AREA CODE. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SMALL HOLES IN THE PLASTIC PORTION OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER CAUSED LEAKAGE OUTSIDE OF THE VEIN DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE COMPLAINT HAS BEEN THAT THERE ARE SMALL PERFORATIONS IN THE PLASTIC PORTION OF THE CATHETER CAUSING LEAKAGE OUTSIDE OF THE VEIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SMALL HOLES IN THE PLASTIC PORTION OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER CAUSED LEAKAGE OUTSIDE OF THE VEIN DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE COMPLAINT HAS BEEN THAT THERE ARE SMALL PERFORATIONS IN THE PLASTIC PORTION OF THE CATHETER CAUSING LEAKAGE OUTSIDE OF THE VEIN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616510 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H10 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown