BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II IV CATHETER

    MDR report key: 3952036 · Received July 17, 2014

    Report

    Report Number
    2243072-2014-00147
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 17, 2014
    Manufacturer
    BD
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVALUATION. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DEVICE WAS INSERTED INTO A PREGNANT WOMEN WITHOUT COMPLICATIONS. NO ABNORMALITIES WERE OBSERVED WHEN PRIMING, HOWEVER, THE INFUSION POINT SWELLED 10 MINUTES AFTER INFUSION BEGAN. THE NURSE REMOVED THE DEVICE, BUT FOUND THE CATHETER WAS SHORTER THAN NORMAL. THE VEIN WAS DISSECTED TO REMOVE THE REMAINING CATHETER TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420266 BD INTIMA-II IV CATHETER INTRAVASCULAR CATHETER FOZ BD 4050118

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention