MEDEX 3-WAY STOPCOCK EXTENSION SET

Additional Manufacturer Narrative

NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS STATED THAT THE LINE KEPT BREAKING AND RESULTED IN BLOOD LOSS. THE EVENT OCCURRED DURING INFUSION AND MONITORING. THE EVENT OCCURRED AT CTICU AND ADDITIONAL INTERVENTIONS AND MONITORING REQUIRED.

Additional Manufacturer Narrative

NEITHER SAMPLES NOR PICTURES WERE RECEIVED FOR THE ANALYSIS OF THIS COMPLAINT. A LOT NUMBER WAS NOT PROVIDED THEREFORE LOT HISTORY REVIEW CANNOT BE PERFORMED. THE REPORTED ISSUE WAS NOT CONFIRMED, AND A PROBABLE CAUSE WAS NOT ABLE TO BE DETERMINED.