BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA¿ II PLUS CLOSED IV CATHETER SYSTEM

    MDR report key: 7956367 · Received October 11, 2018

    Report

    Report Number
    3006948883-2018-00215
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 18, 2018
    Report Date
    October 30, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K172204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REPORT WAS CONDUCTED FOR LOT NUMBER 8043065. DURING OUR REVIEW, NO ABNORMALITIES RELATED TO THIS EVENT WERE FOUND TO HAVE OCCURRED DURING OUR MONITORING OF THE MANUFACTURING PROCESS. ACCORDING TO OUR RECORDS THIS LOT OF INTIMA II WAS MANUFACTURED MARCH 2018; THIS IS THE SECOND INSTANCE OF THIS ISSUE BEING REPORTED FOR THIS LOT. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED, WITH NO DEFECTS BEING NOTED DURING FINAL ASSEMBLY OR IN PACKAGING VISUAL INSPECTIONS. SAMPLES AND PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION AND TESTING. MEASUREMENTS OF THE PHYSICAL DIMENSIONS OF THE RETURNED DEVICES DETERMINED THAT THEY WERE OUT OF SPECIFICATION FOR SWAGE DEPTH, MAKING THE CAVITY TOO NARROW TO HOLD THE TUBING ADEQUATELY. VISUAL OBSERVATION OF THE TUBING DETERMINED THAT IT HAD MARKINGS CONSISTENT WITH THIS, LEADING TO LEAKAGE BETWEEN THE TUBING AND THE ADAPTOR. A REVIEW OF THE MANUFACTURING PROCESS DETERMINED THAT THE ROOT CAUSE IS AN OBSTRUCTION OF THE SWAGING STATION¿S GUIDING CAMERA DURING PRODUCTION. ALTHOUGH THIS IS A RARE OCCURRENCE, IT IS POSSIBLE FOR THE EXTENSION TUBING TO FALL OFF THE PRODUCTION LINE IN A WAY THAT ALLOWS IT TO SETTLE INTO A POSITION THAT OBSTRUCTS THE GUIDING CAMERA¿S EYE, CAUSING THE SWAGING PROCESS TO TERMINATE PRIOR TO COMPLETION. THE PLANT IS EXPECTED TO FINISH OPTIMIZING THE CAMERA SYSTEM BY THE END OF THE MONTH TO ADDRESS THIS EVENT. UNTIL COMPLETION, THE SAMPLING SIZE FOR PRODUCT INSPECTIONS HAS BEEN INCREASED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INTIMA II PLUS CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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 WITH THE USE OF THE BD INTIMA¿ II PLUS CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796724 BD INTIMA¿ II PLUS CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8043065

    Patients

    Seq Age Sex Outcome Treatment
    1 Other