CUSTOM EPIDURAL SINGLE SHOT TRAY

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 REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS FOREIGN BLACK PLASTIC IN THE SEALED TRAY. THE PRODUCT FAULT OCCURRED DURING PATIENT USAGE. IT WAS FREELY FLOATING, WAS SET ASIDE, AND SAVED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

WHILE PERFORMING A REVIEW OF COMPLAINT FILE (B)(4), IT WAS DISCOVERED THAT THE FILE WAS INADVERTENTLY ASSESSED AS REPORTABLE. THERE WAS NO PATIENT DEATH, NO SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. REPORT REFERENCE NUMBER 1217052-2024-00062 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH IT.