BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM 18 G X 1.16 IN.

    MDR report key: 6501633 · Received April 18, 2017

    Report

    Report Number
    3006948883-2017-00006
    Event Type
    Injury
    Date Received
    April 18, 2017
    Date of Event
    March 29, 2017
    Report Date
    May 22, 2017
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K143610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC INSPECTION REVEALED THE CATHETER WAS BROKEN APPROXIMATELY 5MM FROM THE TOP. THE LEFT SIDE OF THE BROKEN CATHETER WAS SMOOTH AND THE RIGHT SIDE WAS JAGGED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6172124. A MANUFACTURING REVIEW REVEALED NO DEFECTS WITHIN THE INCOMING AND ASSEMBLY PROCESSES. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. OUR QUALITY ENGINEER ALSO NOTES THAT THE CUSTOMER'S REPORTED DEFECT IS NOT RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM 18 G X 1.16 IN. BROKE OFF IN USE AND THE PATIENT HAD SURGERY TO REMOVE THE BROKEN CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283317 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM 18 G X 1.16 IN. INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 6172124

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention