UMBILICAL CATHETER SINGLE LUMEN 5FR

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE UMBILICAL CATHETER WAS INSERTED AND THEN WAS NOTED TO NOT HAVE ANY MEASUREMENT MARKINGS ON. IT WAS ALREADY INSERTED WHEN THE TEAM REALIZED THIS. NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

ACCORDING TO THE DHR REVIEW, PARAMETERS DOCUMENTED, AND QUALITY TESTS PERFORMED FOR THE REPORTED LOT NUMBER, THE LOT WAS MANUFACTURED ACCORDING TO STANDARDS. THERE WERE NO DISCREPANCIES THAT COULD BE RELATED TO THE EVENT REPORTED. THE LOT WAS RELEASED ACCORDING TO PRODUCT REQUIREMENTS. ADDITIONALLY, IT WAS DETERMINED THAT THERE WERE NO NCRS RELATED TO THIS LOT NUMBER. THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION, PICTURES OR VIDEOS WERE RECEIVED. CONSEQUENTLY, IT WAS NOT POSSIBLE TO EVALUATE THE AFFECTED DEVICE AS PART OF A COMPREHENSIVE FAILURE INVESTIGATION. IT IS IMPORTANT TO NOTE THAT THERE ARE CONTROLS IN PLACE TO PREVENT THE REPORTED ISSUE FROM OCCURRING INCLUDING PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR THE RAW MATERIAL, IN-PROCESS MATERIAL, AND FINISHED GOODS THAT ARE BASED ON ACCEPTANCE CRITERIA. IN ADDITION, THERE IS A STATION ON THE MANUFACTURING LINE THAT VERIFIES THE CORRECT POSITIONING OF THE DEPTH MARKS AND A SYSTEM THAT HAS VISUAL AIDS FOR UNITS PLACEMENT. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE COULD NOT BE DETERMINED. NO ACTIONS ARE REQUIRED AT THIS TIME. IF THE SAMPLE IS RETURNED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED FOR FURTHER INVESTIGATION. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.