3.5FR DUAL-LUMEN UVC CATH

Additional Manufacturer Narrative

THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT NORMALLY THE CLEAR LUMEN IS LABELLED PRIMARY AND THE BLUE LUMEN IN LABELLED SECONDARY. THEY DISCOVERED THE CLEAR LUMEN WAS LABELLED SECONDARY AND THE BLUE LUMEN WAS LABELLED PRIMARY. PER ADDITIONAL INFORMATION RECEIVED, THE UMBILICAL VENOUS CATHETER (UVC) WAS PLACED IN A BABY AND THE LINE BECAME OBSTRUCTED; THEREFORE, THE UVC NEEDED TO BE REMOVED AND THEY NEEDED CENTRAL LINE ACCESS. THERE WAS NO ADVERSE EVENTS OR INJURIES TO PATIENT. BOTH LUMENS WERE NOTED TO BE OCCLUDED. BOTH LUMENS WERE BEING USED FOR INFUSION. THE UVC WAS INFUSING TOTAL PARENTERAL NUTRITION (TPN) AND ANTIBIOTICS AMPICILLIN AND GENTAMICIN. THERE WAS A DELAY IN BEING ABLE TO DELIVER NUTRITION TO THE BABY ONCE THE UVC WAS OCCLUDED AS IT NEEDED TO BE REMOVED AND INTRAVENOUS LINE (IV) ACCESS WAS AN ISSUE. PERIPHERAL INTRAVENOUS LINE (PIV) ACCESS WAS USED AS A REPLACEMENT. THERE WERE NO OTHER MEDICAL INTERVENTIONS. THE PATIENT IS CURRENTLY STABLE AND STILL ON RESPIRATORY SUPPORT AND FULL FEEDS. THE SAMPLE IS AVAILABLE FOR RETURN.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND REVEALED NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO A COMPLAINT OF THIS FAILURE MODE. ALL QUALITY ASSURANCE TESTING PERFORMED DURING MANUFACTURING WAS ACCEPTABLE. THE QUALITY ASSURANCE REVIEW OF THE VISUAL, PHYSICAL, AND DIMENSIONAL EVALUATION RESULTS CONCLUDES THE PRODUCT MET SPECIFICATION REQUIREMENTS. IN ADDITION, ALL DHRS ARE REVIEWED PRIOR TO THE PRODUCT RELEASE TO CONFIRM ALL REQUIREMENTS WERE MET. THE DEVICE WAS MANUFACTURED ON MARCH 26, 2020. A PHYSICAL SAMPLE WAS NOT RECEIVED FOR THE INVESTIGATION. HOWEVER, ONE PHOTO WAS PROVIDED FOR VISUAL EVALUATION. THE PHOTO SHOWS THAT THE BLUE LUMEN CONTAINS THE PRIMARY EXTENSION INFORMATION, AND THE CLEAR LUMEN CONTAINS THE SECONDARY EXTENSION INFORMATION. WITHOUT A PHYSICAL SAMPLE, THE REPORT OF AN OCCLUSION COULD NOT BE CONFIRMED, HOWEVER; THE REPORTED ISSUE OF THE LUMENS BEING PRINTED INCORRECTLY WAS CONFIRMED. A ROOT CAUSE ANALYSIS INDICATED THAT THIS ISSUE OCCURRED BECAUSE OF HUMAN ERROR DURING THE MANUFACTURING PROCESS. THE ISSUE WAS REPLICATED ON THE MANUFACTURING LINE BY THE INVESTIGATION TEAM, AND IT WAS CONFIRMED THAT THE LUMENS CAN BE PRINTED INCORRECTLY IF THE PROCEDURE OR VISUAL AIDS ON THE MACHINES ARE NOT FOLLOWED PROPERLY. IN ADDITION, THE PROCEDURE WAS FOUND TO HAVE AN AREA OF IMPROVEMENT FOR THE LEVEL OF DETAIL REGARDING THE INSPECTION OF THE INFORMATION POSITIONING PRINTED ON THE EXTENSIONS. AS PART OF CONTINUOUS IMPROVEMENTS, A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS OPENED TO PREVENT THE RECURRENCE OF THE CONFIRMED CONDITION. APPLICABLE DISCIPLINARY ACTIONS WERE IMPLEMENTED FOR THE INVOLVED PERSONNEL, A QUALITY ALERT WAS ISSUED FOR ALL APPROPRIATE PERSONNEL SUMMARIZING THIS RECENT EVENT TO HEIGHTEN AWARENESS, AND THE PROCEDURE HAS BEEN UPDATED TO CLARIFY THE STEPS TO FOLLOW TO ENSURE THE EXTENSIONS ARE PRINTED CORRECTLY. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE RECORDED FOR TRACKING AND TRENDING PURPOSES.