CATHETER, PERITONEAL

Additional Manufacturer Narrative

THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, ON (B)(6) 2017, DURING USE, THE PATIENT INCURRED PERITONITIS CAUSED BY A HOLE ON THE CATHETER. THE DOCTOR GAVE A PAIN KILLER INJECTION FOR THE TREATMENT AND PERITONEAL DIALYSIS WAS STOPPED DURING THE TREATMENT. THE BROKEN CATHETER HAS BEEN REMOVED AND DISCARDED. THE PATIENT IS RECOVERING.

Additional Manufacturer Narrative

BECAUSE NO LOT NUMBER WAS PROVIDED, A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW OR PRODUCT/PROCESS CHANGES REVIEW FOR THE INVOLVED LOT NUMBER COULD NOT BE PERFORMED. HOWEVER, ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. THE ACTUAL SAMPLE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION, PICTURES OR VIDEOS WERE RECEIVED. CONSEQUENTLY, IT WAS NOT POSSIBLE TO EVALUATE IT AS PART OF A COMPREHENSIVE FAILURE INVESTIGATION AND NO PROBABLE CAUSE WAS IDENTIFIED. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. NO TRENDS OR TRIGGERS HAVE BEEN FOUND. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NOT DEEMED NECESSARY AT THIS TIME. IT MUST BE NOTED THAT IN-PROCESS CONTROLS ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.