BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VENFLON INTRAVASCULAR CATHETER 20 G X 1

    MDR report key: 4202190 · Received October 13, 2014

    Report

    Report Number
    2243072-2014-00247
    Event Type
    Injury
    Date Received
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BD
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. TWO POTENTIAL LOT NUMBERS WERE PROVIDED IN REGARDS TO THESE INCIDENTS: 14D1441 AND 14D1841. AN INVESTIGATION WILL BE PERFORMED BASED ON THE PROVIDED INFORMATION, AND UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FROM A PERIOD BETWEEN (B)(6) 2014, APPROXIMATELY 8-9 VOLUNTEERS WERE DIAGNOSED WITH PHLEBITIS AFTER A BD VENFLON INTRAVASCULAR CATHETER WAS USED FOR BLOOD COLLECTION AND FLUSHED WITH NORMAL SALINE. THIS VOLUNTEER RECEIVED ANALGESIC, ANTI-INFLAMMATORY, ANTIBIOTIC, THROMBOLYTIC, AND ANTIPLATELET MEDICATIONS TO TREAT THE PHLEBITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648945 BD VENFLON INTRAVASCULAR CATHETER 20 G X 1 INTRAVASCULAR CATHETER FOZ BD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention