ARROW PERITONEAL LAVAGE CATH KIT:8FR

Additional Manufacturer Narrative

QN#(B)(4). ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON (B)(6) 2024 INDICATES "PRE PROCEDURE US AND FLUOROSCOPY IMAGES SHOWED THE CATHETER CUT IN TO TWO PARTS: SUPERFICIAL AND DEEP. ONE REMOVED VIA FLUOROSCOPY GUIDED [17/08 AT 1324H (SUPERFICIAL/SUBCUTANEOUS) BUT (THE DEEP, INTRA PERITONEAL) CANNOT BE RETRIEVED. SECOND ONE, (THE DEEP OR INTRAPERITONEAL FOREIGN BODY) RETRIEVED VIA LAPAROSCOPIC EXPLORATION [17/08 AT 2246H]." IT WAS ALSO REPORTED THAT "THE PATIENT UNDERWENT 2 INVASIVE PROCEDURES TO RETRIEVE THE FOREIGN BODIES." THE PATIENT CONDITION WAS REPORTED AS "STABLE" AFTER SURGERY.

Description of Event or Problem

CUSTOMER REPORTED "PATIENT COMPLAIN OF PAIN ON SITE WHEN CHECKED, THE TUBE SITE LEAKING AND PERITONEAL CATHETER WAS LEFT INSIDE PATIENT , RESULTING PATIENT FOR SURGERY ".

Additional Manufacturer Narrative

(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. 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.

Description of Event or Problem

CUSTOMER REPORTED "PATIENT COMPLAIN OF PAIN ON SITE WHEN CHECKED, THE TUBE SITE LEAKING AND PERITONEAL CATHETER WAS LEFT INSIDE PATIENT , RESULTING PATIENT FOR SURGERY ". ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT.

Description of Event or Problem

CUSTOMER REPORTED "PATIENT COMPLAIN OF PAIN ON SITE WHEN CHECKED, THE TUBE SITE LEAKING AND PERITONEAL CATHETER WAS LEFT INSIDE PATIENT , RESULTING PATIENT FOR SURGERY ". ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4)