BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17515628 · Received August 11, 2023

    Report

    Report Number
    3006948883-2023-00087
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 27, 2023
    Report Date
    September 3, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K200891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 31-JUL-2023. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 3080087 . OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE WAS RETURNED TO AID IN OUR INVESTIGATION. FUNCTIONAL TESTING OF THE DEVICE WAS ABLE TO IDENTIFY A LEAK IN THE CATHETER TUBING. THIS EVENT HAS BEEN CONFIRMED. MICROSCOPIC INSPECTION OF THE LEAKING AREA WAS SUFFICIENT IDENTIFY A V-SHAPED INCISION ON THE CATHETER TUBING. THIS TYPE OF DAMAGE IS INDICATIVE OF THE NEEDLE PUNCTURE AFTER ATTEMPTED RE-INSERTION DURING USE. DURING PRODUCTION NEEDLES ARE INSERTED AUTOMATICALLY AND ONLY ONE ATTEMPT IS MADE. IN THE CASE OF A PRODUCTION RELATED PIERCE THROUGH THE DEVICE WOULD NOT HAVE BEEN USEABLE DUE TO THE FORKED ORIENTATION RESULTING IN INABILITY TO FEED THE CATHETER TUBING INTO THE PATIENTS VEIN.

    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 WHILE USING THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKAGE WAS FOUND. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE DEALER REPORTED TO SALES: THE ONCOLOGY DEPARTMENT USED INDWELLING NEEDLES FOR PATIENTS AND FOUND FLUID LEAKAGE, WHICH WAS VERY SERIOUS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKAGE WAS FOUND. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE DEALER REPORTED TO SALES: THE ONCOLOGY DEPARTMENT USED INDWELLING NEEDLES FOR PATIENTS AND FOUND FLUID LEAKAGE, WHICH WAS VERY SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563380 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080087

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown