BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8911826 · Received August 20, 2019

    Report

    Report Number
    1710034-2019-00904
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    August 6, 2019
    Report Date
    September 27, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903826446
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPH PROVIDED. BD RECEIVED FIVE UNUSED, INSYTE AUTOGUARD BC 18GA UNITS FROM MATERIAL NUMBER 3872644. ONE UNIT WAS FULLY RETRACTED IN AN OPENED PACKAGE AND THE REMAINING FOUR UNITS WERE UNUSED IN SEALED PACKAGES. ONE PHOTO WAS SUBMITTED FOR REVIEW WHICH DISPLAYED AN 18GA WINGED UNIT WITH THE NEEDLE THROUGH THE CATHETER NEAR THE TIP OF THE CATHETER TIP. THE REPORTED ISSUE WAS CONFIRMED AS THE UNIT IN THE OPENED PACKAGE DISPLAYED A CUT (V-SHAPED) ON THE CATHETER TUBING NEAR THE TIP. THE V-SHAPED CUT ON THE UNIT WAS CAUSED BY THE NEEDLE TIP SPEARING THROUGH THE CATHETER. THE UNITS IN THE SEALED PACKAGES REVEALED NO DAMAGE. DUE TO THE PACKAGING BEING OPENED ON THE UNIT THAT REVEALED THE DEFECT, IT IS UNKNOWN IF THIS DEFECT OCCURRED DURING MANIPULATION OF THE PRODUCT AT USER ENVIRONMENT OR DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER SHEATH WAS FOUND "TORN/RIPPED" BEFORE USE DUE TO THE NEEDLE PIERCING THROUGH IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BOTH 20G AND 18G CATHETERS HAVE SHEATH COVERING TORN/RIPPED : THIS IS NOTED WHEN PACKAGE OPENED AND CAP REMOVED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER SHEATH WAS FOUND "TORN/RIPPED" BEFORE USE DUE TO THE NEEDLE PIERCING THROUGH IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BOTH 20G AND 18G CATHETERS HAVE SHEATH COVERING TORN/RIPPED ¿ THIS IS NOTED WHEN PACKAGE OPENED AND CAP REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707366 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8310619 30382903826446

    Patients

    Seq Age Sex Outcome Treatment
    1 Other