BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 18414071 · Received December 28, 2023

    Report

    Report Number
    1710034-2023-01489
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    November 12, 2023
    Report Date
    January 18, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED TWO PHOTOGRAPHS WHICH DISPLAYED THE 22GX1.00IN INSYTE AUTOGUARD UNIT FROM LOT NUMBER 3192172 AND A UNIT WITH DRIED MEDIA AND A DAMAGED CATHETER TIP. THE OBSERVED DAMAGE IS IDENTICAL TO THAT CREATED WHEN THE NEEDLE PIERCES THE CATHETER WALL NEAR THE TIP CAUSING A SPEAR THROUGH. THE REPORTED ISSUE WAS CONFIRMED. THE NEEDLE CAN PIERCE THE CATHETER DURING USE OR MANUFACTURING OF THE DEVICE. AS THE UNIT IS OBSERVED TO HAVE BEEN USED, IT IS UNLIKELY THAT THE DAMAGE OCCURRED DURING MANUFACTURING. HAD THE DEFECT OCCURRED DURING MANUFACTURING, THE CONDITION OF THE CATHETER AND NEEDLE WOULD RENDER THE DEVICE UNUSABLE. IT IS LIKELY THAT THE NEEDLE AND CATHETER WERE INSERTED FAR ENOUGH TO ACCESS THE VESSEL, AFTER WHICH THE NEEDLE WAS RETRACTED AND REINSERTED TO PUNCTURE THE CATHETER. THE IFU(INSTRUCTIONS FOR USE) INDICATE THAT IF THE NEEDLE IS PARTIALLY OR COMPLETELY WITHDRAWN FROM THE CATHETER TUBING DURING INSERTION, DO NOT RE-INSERT THE NEEDLE INTO THE CATHETER TUBING AS DAMAGE MAY OCCUR. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WAS SHEARED BY THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DATE: (B)(6) 2023. DESCRIPTION: CATH IV INSYTE AUTOGUARD PIV BLU 22GAX1. ISSUE: STARTED 22 GAUGE X 1 INCH INSTYLE AUTOGUARD IN LEFT AC, CATHETER WOULD NOT ADVANCE AND FOUND INTACT BUT SHEARED FROM NEEDLE FOLLOW UP: WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? YES. NEEDED TO REPLACE PRODUCT. CAN YOU PROVIDE A EXACT DATE OF EVENT? (B)(6) 2023. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? YES. I NOTED THAT THERE WAS A "BUBBLE" WHERE THE CATHETER WAS UNDER THE SKIN. I PULLED THE NEEDLE WITH CATHETER OUT AND APPLIED PRESSURE. THE CATHETER WAS INTACT BUT SHEARED FROM NEEDLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400951 BD INSYTE AUTOG BC PERIPHERAL IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3192172 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown