CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT C

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. BROKEN CLIPS WERE DETECTED IN TWO SAMPLES. 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 BLUE CLIP BECAME BROKEN AFTER THE PRODUCT LEFT SHM FACILITIES. NO CORRECTIVE ACTIONS ARE REQUIRED SINCE IT?S UNLIKELY THAT THE BLUE CLIP WAS BROKEN DURING THE MANUFACTURING PROCESS. 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 IMMEDIATELY AFTER OPENING THE PACKAGE, THE CUSTOMER NOTICED THE HOOKS OF THE BLUE CLIP BROKE OFF. 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 3012307300-2022-07848 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY MDR REPORTS ASSOCIATED WITH IT.