BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8327395 · Received February 11, 2019

    Report

    Report Number
    3006948883-2019-00130
    Event Type
    Malfunction
    Date Received
    February 11, 2019
    Date of Event
    January 21, 2019
    Report Date
    March 12, 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 8171152. 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 ASSOCIATED WITH THE AT THE CONCLUSION OF OUR REVIEW. CUSTOMER RETURNED 1 SAMPLE, GAUGE IS 24G, CAT 383083. FM WAS FOUND ON TUBE NEAR THE Y-CONNECTOR. AS PER REQUEST, FTIR ANALYSIS WAS COMPLETED ON THE YELLOW MATERIAL OBSERVED IN THE TUBING OF THE SAMPLE. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY CRYSTALLIZED MEDICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH WHITE FOREIGN MATTER IN TUBING NEAR PRN.

    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¿ CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH WHITE FOREIGN MATTER IN TUBING NEAR PRN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117839 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8171152

    Patients

    Seq Age Sex Outcome Treatment
    1 Other