NRFIT INFUSION DISPOSABLES PORTFOLIO WITH NRFIT

Description of Event or Problem

IT WAS REPORTED THAT THE PRODUCT COULD NOT BE DISCONNECTED FROM THE CASSETTE. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. CUT TUBE WAS FOUND. A REVIEW OF THE MANUFACTURING PROCESS FOR WAS CONDUCTED BY QUALITY ENGINEER IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT. NO DISCREPANCIES WERE FOUND. THE MOST PROBABLE ROOT CAUSE IS THAT THE PRODUCT BECAME DAMAGED AFTER IT LEFT THE MANUFACTURING FACILITY. NO CORRECTIVE ACTIONS ARE REQUIRED SINCE IT?S UNLIKELY THAT CAP WAS DAMAGED DURING THE MANUFACTURING PROCESS. A NOTIFICATION OF THE REPORTED FAILURE MODE TO THE PRODUCTION PERSONNEL WAS CONDUCTED BY THE QUALITY ENGINEER.

Additional Manufacturer Narrative

OTHER TEXT: WHILE PERFORMING A REVIEW OF SUBMITTED MDR REPORT IT WAS DISCOVERED THAT THIS FILE WAS INADVERTENTLY ASSESSED AS REPORTABLE. NO PATIENT DEATH, 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 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY MDR REPORTS ASSOCIATED WITH IT.

Description of Event or Problem

IT WAS REPORTED THAT THE PRODUCT COULD NOT BE DISCONNECTED FROM THE CASSETTE. NO PATIENT INJURY WAS REPORTED.