CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT CON

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. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT THE CONNECTOR WAS FOUND DAMAGED DURING FILLING. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

OTHER, 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 3012307300-2022-07933 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY MDR REPORTS ASSOCIATED WITH IT.