ARROW HEMODIALYSIS KIT: 2L 14 FR X 15 CM

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED "CATHETER CAME DISLODGED FROM WHITE SUTURE WINGS AND DISLODGED FROM PATIENT." THE LINE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

Description of Event or Problem

IT WAS REPORTED "CATHETER CAME DISLODGED FROM WHITE SUTURE WINGS AND DISLODGED FROM PATIENT." THE LINE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

Additional Manufacturer Narrative

QN# (B)(4). THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS. THE COMPLAINT OF MIGRATED CATHETER WAS CONFIRMED THROUGH ANALYSIS OF THE CUSTOMER SUPPLIED PHOTO. VISUAL ANALYSIS REVEALED THAT THE CATHETER BODY HAD DISLODGED FROM THE ROTATING SUTURE WING. SUTURES WERE VISIBLE ON THE SUTURE WINGS. THE ROTATING SUTURE WING COMPONENT IS NOT MOLDED OR ADHERED TO THE JUNCTURE HUB. THEREFORE, IT IS POSSIBLE FOR THE SUTURE WING TO DETACH IF UNDUE FORCE IS APPLIED; HOWEVER, A COMPLETE VISUAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. R & D WAS CONTACTED AS A PART OF THIS COMPLAINT INVESTIGATION. THEY CONFIRMED THAT THE SUTURE WING IS NOT MOLDED TO THE JUNCTURE HUB; HOWEVER, LARGE AMOUNTS OF UNDUE FORCE WOULD BE REQUIRED TO DISLODGE. THE SAMPLE WOULD NEED TO BE RETURNED IN ORDER TO VERIFY IF ANY ADDITIONAL DAMAGES ARE PRESENT. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "USE TRIANGULAR JUNCTURE HUB WITH INTEGRAL ROTATING SUTURE WINGS AS PRIMARY SUTURE SITE". THE IFU ALSO STATES, "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". THE CUSTOMER REPORT OF A MIGRATED CATHETER WAS CONFIRMED BY VISUAL INSPECTION OF THE CUSTOMER SUPPLIED PHOTO. REVIEW OF THE PHOTO REVEALED THAT THE CATHETER BODY HAD DISLODGED FROM THE ROTATING SUTURE WING. IT IS POSSIBLE FOR THE SUTURE WING TO DETACH IF UNDUE FORCE IS APPLIED TO THE CATHETER, HOWEVER, FULL COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. WITHOUT THE DEVICE TO EVALUATE, THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.