BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 8750701 · Received July 1, 2019

    Report

    Report Number
    3006948883-2019-00502
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 10, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    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 REVIEW WAS CONDUCTED FOR LOT NUMBER 9023794. 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. ADDITIONALLY, OUR ENGINEERS WERE ABLE TO EVALUATE THE EXPANDED TUBING IN THE DEVICE SUBMITTED. BASED ON THEIR EVALUATION AND THE DESCRIPTION OF THE EVENT, THEY WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE FORCING OF FLUID THROUGH THE DEVICE DURING INJECTION. THE BD INTIMA-II IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA II¿ IV CATHETER PRN ADAPTER TUBING WAS DAMAGED AND LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND TUBING DAMAGED DURING THE CT SCAN ACCORDING TO PROCESS, LEADING TO MEDICINE LEAKAGE. PRESSURE WAS NO MORE THAN 200 PSI.

    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 BD INTIMA II¿ IV CATHETER PRN ADAPTER TUBING WAS DAMAGED AND LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND TUBING DAMAGED DURING THE CT SCAN ACCORDING TO PROCESS, LEADING TO MEDICINE LEAKAGE. PRESSURE WAS NO MORE THAN 200 PSI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542259 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9023794

    Patients

    Seq Age Sex Outcome Treatment
    1 Other