BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 15777259 · Received November 10, 2022

    Report

    Report Number
    1710034-2022-00675
    Event Type
    Malfunction
    Date Received
    November 10, 2022
    Date of Event
    October 17, 2022
    Report Date
    December 5, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPH PROVIDED FOR EVALUATION. BD RECEIVED TWO UNSEALED 20GA X 1.00IN INSYTE AUTOGUARD BC UNITS FROM LOT NUMBER 2220955. ADDITIONALLY, ONE PHOTO WAS PROVIDED. THE PHYSICAL SAMPLE WITH A BROKEN NEEDLE WAS NOT RETURNED FOR INVESTIGATION, BUT A PHOTOGRAPH WAS PROVIDED, WHICH SHOWED A BREAK IN THE NEEDLE. THE REPORTED ISSUE WAS CONFIRMED HOWEVER WITHOUT THE ACTUAL SAMPLE A ROOT CAUSE COULD NOT BE DETERMINED. THE RETURNED UNITS DID NOT DISPLAY ANY DAMAGE TO THE NEEDLE. UNIT 1 HAD THE CATHETER ADAPTER STUCK INSIDE THE NEEDLE COVER AND THE NEEDLE WAS ALREADY RETRACTED. UNIT 2 DISPLAYED A NEEDLE SPEAR THROUGH. BOTH UNITS WERE UNSEALED AND OUT OF THE PACKAGE. THE RETURNED PHYSICAL DEVICES DID NOT DISPLAY ANY DAMAGE TO THE NEEDLE AND THE DEFECTS DISCOVERED FOR THE PHYSICAL UNITS WAS UNRELATED TO YOUR REPORTED ISSUE. BECAUSE THE DEVICES WERE RECEIVED OPENED, IT COULD NOT BE DETERMINED IF THE DAMAGE RESULTED FROM THE MANUFACTURING OF THE DEVICE OR FROM THE USER ENVIRONMENT. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE WAS FOUND BROKEN WHEN REMOVING IT FROM THE PACKAGING. THIS OCCURRED WITH 2 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AN INSYTE IV CATHETER THAT THE NEEDLE WAS IN TWO PIECES WHEN IT CAME OUT OF THE PACKAGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE WAS FOUND BROKEN WHEN REMOVING IT FROM THE PACKAGING. THIS OCCURRED WITH 2 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AN INSYTE IV CATHETER THAT THE NEEDLE WAS IN TWO PIECES WHEN IT CAME OUT OF THE PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2877775 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382533 2220955 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown