BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA¿ II PLUS CLOSED IV CATHETER SYSTEM

    MDR report key: 7901436 · Received September 24, 2018

    Report

    Report Number
    3006948883-2018-00192
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    September 3, 2018
    Report Date
    October 25, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830800
    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

    IN RESPONSE TO THE EVENT REPORTED BY THE FACILITY A DEVICE HISTORY REPORT WAS CONDUCTED FOR LOT NUMBER 8043065, AND NO RELATED ABNORMALITIES WERE FOUND. THIS LOT OF INTIMA II WAS MANUFACTURED MARCH 2018; IT WAS DETERMINED THAT THIS IS THE SECOND INSTANCE OF LEAKAGE OCCURRING AT THIS LOCATION IN 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 VISUAL INSPECTIONS. ALTHOUGH SAMPLES WERE NOT RETURNED BY THE FACILITY, SIMILAR COMPLAINTS HAVE SHOWN THE FOLLOWING. 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 A 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 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. BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INTIMA II PLUS CLOSED IV CATHETER SYSTEM HAD LEAKAGE AT THE TUBING JUNCTION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS 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 THAT A BD INTIMA¿ II PLUS CLOSED IV CATHETER SYSTEM HAD LEAKAGE AT THE TUBING JUNCTION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744894 BD INTIMA¿ II PLUS CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8043065 00382903830800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other