ECHOGLO CONTINUOUS NERVE BLOCK NEEDLE

Description of Event or Problem

IT WAS REPORTED THAT THE CATHETER DOES NOT SLIDE SMOOTHLY THROUGH THE NEEDLE. THE TIP OF THE NEEDLE CREATES TOO MUCH RESISTANCE. THE DOCTOR CANNOT FEEL WHETHER THE CATHETER IS GOING TO THE RIGHT PLACE. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

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.

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 9616567-2024-00117 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH IT.