UMBILICAL CATHETER

Additional Manufacturer Narrative

ALTHOUGH THE MALFUNCTIONING DEVICE WILL NOT BE RETURNED TO VYGON, THE DETAILS OF THE MALFUNCTION WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO THE FDA.

Description of Event or Problem

UMBILICAL VENOUS LINE BEING PLACED IN AN INFANT WHO WAS NPO FOR ACCESS AND MEDICATIONS. STOPCOCK WAS ATTACHED TO THE LINE PRIOR TO INSERTION WITHOUT INCIDENT. LINE WAS PLACED, CONFIRMED BY RADIOGRAPH TO BE IN GOOD PLACEMENT AND CONNECTED TO MAINTENANCE FLUIDS. IT RAN FOR SEVERAL HOURS BEFORE MOISTURE WAS NOTED NEAR THE STOPCOCK BY THE RN CARING FOR THE PATIENT. A STERILE 4X4 WAS WRAPPED AROUND THE STOPCOCK AND WHEN THAT WAS NOTED TO BE WET AFTER A FEW MINUTES, THE LINE WAS REMOVED AND REPLACED WITH A NEW CATHETER. WHEN THE REMOVED LINE WAS EXAMINED, THE HUB OF THE CATHETER WAS NOTED TO BE MISSING A "SHOULDER".

Additional Manufacturer Narrative

THE INVESTIGATION SUMMARY IS AS FOLLOWS: THE DEFECTIVE SAMPLE WAS NOT RETURNED BY THE CUSTOMER. THE ABSENCE OF THE SAMPLE MAKES IT IMPOSSIBLE TO VISUALLY INSPECT THE PRODUCT OR VERIFY THE REPORTED FAULT. ADDITIONALLY, NO IMAGES WERE PROVIDED THAT WOULD ALLOW US TO EVALUATE THE ISSUE. SINCE NEITHER THE FAULTY SAMPLE NOR ANY IMAGES WERE RECEIVED, AN INVESTIGATION COULD NOT BE CONDUCTED, AND THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. A REVIEW OF THE PRODUCTION RECORDS AND QUALITY CONTROL DATA FOR THE REPORTED BATCH WAS CONDUCTED, AND NO ANOMALIES WERE IDENTIFIED. A 100% LEAK TEST IS PERFORMED DURING MANUFACTURING, AND ANY DEFECT ON THE HUB WOULD LIKELY HAVE BEEN DETECTED DURING THIS INSPECTION. BASED ON THE DESCRIPTION OF THE COMPLAINT, WE CAN CONCLUDE THAT THE PRODUCT WAS INITIALLY INTACT. ISSUES SUCH AS THE ONE DESCRIBED CAN OCCUR WHEN EXCESSIVE FORCE IS APPLIED BETWEEN CONNECTIONS, OR WHEN MECHANICAL FORCE IS EXERTED ON THE HUB OF THE CATHETER. THE EXACT CAUSE OF THE FAULT CANNOT BE DETERMINED. FURTHERMORE, TO DATE, THERE HAVE BEEN NO REPORTS OF SIMILAR COMPLAINTS ASSOCIATED WITH THE REPORTED BATCH. CORRECTIVE ACTION: DUE TO THE MISSING SAMPLE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT, AS A ROOT CAUSE ANALYSIS COULD NOT BE CONDUCTED. SHOULD AN ISSUE OCCUR WITH OUR PRODUCT IN THE FUTURE, PLEASE PROVIDE A REPRESENTATIVE PHOTO OR, PREFERABLY, RETURN THE FAULTY SAMPLE FOR EVALUATION.

Description of Event or Problem

UMBILICAL VENOUS LINE BEING PLACED IN AN INFANT WHO WAS NPO FOR ACCESS AND MEDICATIONS. STOPCOCK WAS ATTACHED TO THE LINE PRIOR TO INSERTION WITHOUT INCIDENT. LINE WAS PLACED, CONFIRMED BY RADIOGRAPH TO BE IN GOOD PLACEMENT AND CONNECTED TO MAINTENANCE FLUIDS. IT RAN FOR SEVERAL HOURS BEFORE MOISTURE WAS NOTED NEAR THE STOPCOCK BY THE RN CARING FOR THE PATIENT. A STERILE 4X4 WAS WRAPPED AROUND THE STOPCOCK AND WHEN THAT WAS NOTED TO BE WET AFTER A FEW MINUTES, THE LINE WAS REMOVED AND REPLACED WITH A NEW CATHETER. WHEN THE REMOVED LINE WAS EXAMINED, THE HUB OF THE CATHETER WAS NOTED TO BE MISSING A "SHOULDER".