CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT CO

Additional Manufacturer Narrative

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. SYRINGE PART THAT REMAINED IN THE LUER WAS FOUND. LUER WAS MEASURED TO ENSURE THE INNER DIAMETER IS WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND; INNER DIAMETER IS WITHIN SPECIFICATION. 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. NO ROOT CAUSE HAS TO BE DETERMINED SINCE NO ANOMALIES WERE FOUND IN THE SAMPLE RECEIVED FOR EVALUATION. NO CORRECTIVE ACTIONS ARE REQUIRED SINCE THE COMPLAINT WAS NOT CONFIRMED. A NOTIFICATION OF THE REPORTED FAILURE MODE TO THE PRODUCTION PERSONNEL WAS CONDUCTED BY THE QUALITY ENGINEER.

Description of Event or Problem

IT WAS REPORTED THAT WHEN THE CUSTOMER WAS FILLING UP MEDICAL FLUID INTO THE CASSETTE, THE SYRINGE TIP BROKE OFF AND THE BROKEN PART REMAINED IN THE CONNECTION PART OF THE OF THE TUBE. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

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 3012307300-2022-07865 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY MDR REPORTS ASSOCIATED WITH IT.