5.0FR URETHANE UMB CATH

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD (DHR) WAS NOT POSSIBLE AS THE LOT NUMBER WAS REPORTED AS UNKNOWN. HOWEVER, ALL DHR¿S ARE REVIEWED PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. A SAMPLE ANALYSIS WAS NOT POSSIBLE AS THERE WAS NO PHOTOGRAPHS OR SAMPLES PROVIDED FOR EVALUATION. WITHOUT A SAMPLE TO EVALUATE, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED ISSUE OR RELATED IT TO A MANUFACTURING PROCESS. AS SUCH, THE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. CURRENT PROCESS CONTROLS ARE EXECUTED IN ACCORDANCE WITH PRODUCT SPECIFICATIONS TO MEET QUALITY ACCEPTANCE CRITERIA. 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 PERFORMED IN THE PLANT) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR THE PROCESS, CUSTOMER COMPLAINTS AND FEEDBACK NOTIFICATIONS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. IN THE CASE OF A REPEATED ISSUE AND/OR RECURRENCE, A NEW INVESTIGATION FOR THE SPECIFIC EVENTS WOULD BE CARRIED OUT FOR EACH CASE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE CATHETER IS SHARP AND HARD, IT TWISTS AND CUTS EASILY CAUSING LEAKS, THE INSERTION AND SECURING OF THE LINE IS DIFFICULT, AND IT CAN ONLY STAY IN SITU FOR 5DAYS. PER ADDITIONAL INFORMATION RECEIVED, THE AREA WAS CLEANED WITH CHLORHEXIDINE AND DRIED PRIOR TO INSERTION. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE AS THE DOCTOR INVOLVED DECLINED TO ANSWER ANY FURTHER QUESTIONS. THERE IS NO SUPPORTING EVIDENCE CONFIRMING VEIN PERFORATION OCCURRED.

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 OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.