BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 4173760 · Received September 28, 2014

    Report

    Report Number
    4173760
    Event Type
    Malfunction
    Date Received
    September 28, 2014
    Date of Event
    January 22, 2014
    Report Date
    September 28, 2014
    Manufacturer
    OWEN'S & MINOR
    Product Code
    HRQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ONE SIDE OF THE METAL HEMOSTAT BROKE OFF WHEN THE NURSE CLAMPED IT DOWN ON TUBING WHILE DISCONNECTING TUBING FROM THE PATIENT'S NASOGASTRIC TUBE. THE NURSE REPORTED THAT SHE DID NOT USE EXTRA FORCE USING THE DEVICE.======================MANUFACTURER RESPONSE FOR METAL HEMOSTAT, MEDICHOICE (PER SITE REPORTER).======================IT WAS RETURNED TO THE VENDOR REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604122 MEDICHOICE HEMOSTAT HRQ OWEN'S & MINOR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NG TUBING