PORTEX PAIN MANAGEMENT KIT

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

Description of Event or Problem

IT WAS REPORTED THAT THE CUSTOMER ATTEMPTED TO INJECT THE DRUG SOLUTION INTO THE DEVICE'S CONNECTOR, BUT IT WAS BLOCKED. SINCE THE CATHETER WAS FUNCTIONING NORMALLY, THE CUSTOMER REPLACED THE CONNECTOR AND CONTINUED THE PROCEDURE. THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.

Additional Manufacturer Narrative

DEVICE EVALUATION: ONE DEVICE WAS RECEIVED FOR DEVICE ANALYSIS. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING AND VISUAL INSPECTION PERFORMED DURING ANALYSIS. THE CUSTOMER REPORTED COMPLAINT WAS NOT DUPLICATED OR CONFIRMED. THE PROBABLE CAUSE WAS UNABLE TO BE DETERMINED.