BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8030547 · Received November 1, 2018

    Report

    Report Number
    3006948883-2018-00249
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 26, 2018
    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

    A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8141375. OUR RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED IN JUNE OF 2018 AND DETERMINED THAT THIS IS THE ONLY INSTANCE OF FOREIGN MATTER BEING OBSERVED 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 OF PACKAGED GOODS. ALTHOUGH A SAMPLE WAS SUBMITTED FOR REVIEW, VISUAL EVALUATION OF THE DEVICE WAS UNABLE TO IDENTIFY ANY MATERIAL FOREIGN TO THE DEVICE. LIKEWISE, THE SUBMITTED PHOTOGRAPH WAS NOT ADEQUATE FOR DETERMINING THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    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 FOREIGN MATTER. 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¿ CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867398 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8141375

    Patients

    Seq Age Sex Outcome Treatment
    1 Other