BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II IV CATHETER

    MDR report key: 3963980 · Received July 9, 2014

    Report

    Report Number
    2243072-2014-00141
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 21, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BD
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION REGARDING THE EVENT IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS INSERTED INTO THE PATIENT'S HEAD ON (B)(6) 2014. ON (B)(6) 2014, THE INSERTION POINT WAS RED AND SWOLLEN WITH A PURULENT SECRETION. ANTIBIOTICS WERE GIVEN TO TREAT THE PHLEBITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399068 BD INTIMA-II IV CATHETER INTRAVASCULAR CATHETER FOZ BD 4020064

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Required Intervention DAN VIDARABINE PHOSPHATE| YANHUNING