ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM

Additional Manufacturer Narrative

QN# (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT " WE HAVE NOW HAD 4 OF THESE LINES BECOME DISLODGED DURING ROUTINE NURSING CARE OF CRITICALLY ILL PATIENTS. WHILST A SMALL AMOUNT OF TENSION WILL INEVITABLY BE APPLIED TO THESE LINES, WE HAVE NO EVIDENCE THAT UNDUE FORCE WAS APPLIED. THIS HAS HAPPENED WITH DIFFERENT MEMBERS OF STAFF, IN DIFFERENT PATIENTS, OVER SEVERAL MONTH PERIOD." THERE WAS NO SIGNS OR SYMPTOMS. ADDITIONAL INFORMATION RECEIVED REPORTS THERE WAS "NO TREATMENT FOR 4 HOURS". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00853, 3006425876-2025-00854, AND 3006425876-2025-00855.

Description of Event or Problem

IT WAS REPORTED THAT " WE HAVE NOW HAD 4 OF THESE LINES BECOME DISLODGED DURING ROUTINE NURSING CARE OF CRITICALLY ILL PATIENTS. WHILST A SMALL AMOUNT OF TENSION WILL INEVITABLY BE APPLIED TO THESE LINES, WE HAVE NO EVIDENCE THAT UNDUE FORCE WAS APPLIED. THIS HAS HAPPENED WITH DIFFERENT MEMBERS OF STAFF, IN DIFFERENT PATIENTS, OVER SEVERAL MONTH PERIOD." THERE WAS NO SIGNS OR SYMPTOMS. ADDITONAL INFORMATION RECIEVED REPORTS THERE WAS "NO TREATMENT FOR 4 HOURS". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED".

Additional Manufacturer Narrative

(B)(4). ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER CLARIFYING THAT THERE WAS ONLY ONE EVENT INVOLVING ONE PATIENT. IT WAS REPORTED THAT THE CONDITION OF THE PATIENT WAS "DECEASED" AND THE DATE OF DEATH WAS (B)(6) 2025. THE PATIENT'S REPORTED CAUSE OF DEATH WAS "MULTIPLE ORGAN FAILURE DUE TO CARDIAC ARREST, DUE TO SEPSIS SECONDARY TO INFECTED LEG ULCERS." THE CUSTOMER ALSO REPORTS "FROM THE ICU NOTES, AND SUBSEQUENT DISCUSSIONS WITH THE NURSING TEAM AND MEDICAL TEAM ON DUTY, THE LOSS OF THE RENAL REPLACEMENT ACCESS LINE IS NOT THOUGHT TO HAVE BEEN A SIGNIFICANT CONTRIBUTORY FACTOR IN THE PATIENT'S DEATH." COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, "MINIMIZE CATHETER MANIPULATION THROUGHOUT PROCEDURE TO MAINTAIN PROPER CATHETER TIP POSITION. INDWELLING CATHETERS SHOULD BE ROUTINELY INSPECTED FOR DESIRED FLOW RATE, SECURITY OF DRESSING, CORRECT CATHETER POSITION, AND FOR SECURE LUER-LOCK CONNECTION. USE CENTIMETER MARKINGS TO IDENTIFY IF THE CATHETER POSITION HAS CHANGED." THE IFU ALSO STATES, "USE TRIANGULAR JUNCTURE HUB WITH INTEGRAL ROTATING SUTURE WINGS AS PRIMARY SUTURE SITE. THE REMOVABLE SUTURE WING, WHERE PROVIDED, MAY BE USED AS A SECONDARY SUTURE SITE. PLACE FINGERS ON THE SUTURE WINGS AND APPLY PRESSURE UNTIL THE HUB SPLITS OPEN. POSITION SUTURE WING AROUND THE CATHETER BODY ADJACENT TO THE VENIPUNCTURE SITE. SECURE WINGS IN PLACE TO PATIENT, USING SUTURING TECHNIQUE PER INSTITUTIONAL POLICIES AND PROCEDURES." WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.