BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B-D INFUSELET

    MDR report key: 2073533 · Received April 26, 2011

    Report

    Report Number
    2073533
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 16, 2011
    Manufacturer
    B-D
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PERIPHERAL IV WAS PLACED, BUT THE TUBING EXTENSION SET COULD NOT BE ATTACHED DUE TO A PROBLEM WITH THE CATHETER HUB. TWO MORE ATTEMPTS WERE MADE TO PLACE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B-D INFUSELET ANGIOCATH FOZ B-D 381412 0280776, 2013-10

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR NO OTHER THERAPIES