PORTEX PAIN MANAGEMENT KIT

Additional Manufacturer Narrative

ONE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED TWO KINKS. FUNCTIONAL TESTING WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED PROBLEM. THE ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. NO LOT NUMBER WAS PROVIDED; THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A SUSPECTED BLOCKAGE IN THE CATHETER. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.