BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 17234733 · Received June 29, 2023

    Report

    Report Number
    1710034-2023-00753
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 7, 2023
    Report Date
    August 4, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 28-JUN-2023 H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED TWO UNSEALED 24GA X 0.75IN. INSYTE AUTOGUARD UNITS FROM LOT NUMBER 2178969. ADDITIONALLY, TWO PHOTOS WERE PROVIDED. VISUAL INSPECTION DISCOVERED THAT ONE UNIT DISPLAYED A NEEDLE SPEAR THROUGH NEAR THE TIP OF THE CATHETER. THE SECOND UNIT WAS RECEIVED RETRACTED AND WITH WHAT APPEARED TO BE MEDIA IN THE DEVICE. THE SECOND UNIT ALSO APPEARED TO HAVE DAMAGE TO THE CATHETER TUBING. THE CUT RESEMBLED A NEEDLE SPEAR THROUGH DEFECT. THIS MAY IMPLY THE DEFECT WAS DISCOVERED DURING USE. THE REPORTED DEFECT OF ¿NEEDLE THROUGH CATHETER¿ WAS CONFIRMED. THERE WAS NO FOREIGN MATTER OBSERVED. THIS DEFECT MAY OCCUR IF THE NEEDLE IS ADVANCED AT THE WRONG ANGLE OR IF THE NEEDLE IS MOVED UP AND DOWN THE CATHETER TUBING WHILE THE TUBING IS IN THE VEIN. THE INSTRUCTION FOR USE (IFU) STATES TO HOLD THE NEEDLE ASSEMBLY STATIONARY AFTER INSERTION AND DURING CATHETER ADVANCE. THIS DEFECT MAY ALSO OCCUR DURING TIP ADHESION BREAK OR NEEDLE COVER REMOVAL. SINCE ONE UNIT WAS RECEIVED UNSEALED AND THE OTHER HAD MEDIA PRESENT AND A ¿V-SHAPE¿ CUT ON THE TUBING, THIS DEFECT MOST LIKELY OCCURRED DURING USE. IF THE DEFECT HAD OCCURRED DURING MANUFACTURING, THE DEFECT WOULD BE EVIDENT, AND THE CLINICIAN WOULD NOT HAVE USED THE DEVICE. SINCE THIS DEFECT OCCURRED DURING USE, WHICH IS ALSO CONFIRMED IN THE ENTRY DESCRIPTION WHICH STATES, ¿THE CATHALON ISSUE OCCURRED DURING THE USE OF THE PRODUCT¿, THIS LIKELY OCCURRED IN 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.

    Additional Manufacturer Narrative · 0

    H3. 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 · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER FOREIGN MATTER WAS DISCOVERED IN CANNULA. THIS IS THE 2ND OF 2 MALFUNCTIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT DEFECTIVE DEVICES PHOTOS REVEAL - FOREIGN MATTER IN CANNULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER FOREIGN MATTER WAS DISCOVERED IN CANNULA. THIS IS THE 2ND OF 2 MALFUNCTIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT DEFECTIVE DEVICES PHOTOS REVEAL - FOREIGN MATTER IN CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001225 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381812 2178969 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown