WALKMED 65 ML RESERVOIR BAG

Additional Manufacturer Narrative

(B)(4). A SEPARATE MDR REPORT WAS GENERATED FOR THE THREE (3) PATIENTS WHO WERE USING 5FU MEDICATION AT THE TIME OF THE EVENTS ON (B)(6) 2017. AN MDR REPORT WAS NOT GENERATED FOR THE PHARMACIST WHO DISCOVERED THE LEAK DURING SET UP, AS IT WAS DETERMINED THAT THERE WAS NO POTENTIAL EXPOSURE TO HAZARDOUS MEDICATION RELATED TO THAT PARTICULAR EVENT AND NO INDICATION THAT THERE WOULD BE POTENTIAL FOR SERIOUS INJURY IF THAT PARTICULAR EVENT WERE TO RECUR. THE ACTUAL DEVICE WAS RETURNED TO REXMED, NOT WALKMED, ON 03/03/2017. REXMED OPENED A COMPLAINT, # (B)(4) AND INVESTIGATED THE DEVICE. REXMED CONFIRMED A LEAK IN THE DEVICE LUER LOCK BUT COULD NOT DETERMINE A ROOT CAUSE. NEVERTHELESS AS A CONTAINMENT ACTION, REXMED IS CHECKING THAT THE LUER LOCK HAS NO FISSURE DAMAGE BEFORE THE RESERVOIR BAG HAS BEEN SENT.

Description of Event or Problem

THERE WERE 4 INDIVIDUAL EVENTS INVOLVING A LEAK WITH 4 DIFFERENT WALKMED INFUSION'S IPR BAGS FROM LOT 20816500 (REF 204820, LOT 20816500). EACH EVENT INVOLVED ONE PERSON, FOR A TOTAL FOUR (4) PEOPLE. A TOTAL OF THREE PATIENTS WERE EXPOSED TO MEDICATION DURING THEIR TREATMENT (ON (B)(6) 2017 TWO PATIENTS WERE AFFECTED AND ON (B)(6) 2017 ONE PATIENT WAS AFFECTED). YES 5FU WAS BEING ADMINISTERED. THE LEAK WAS COMING FROM THE SITE BETWEEN THE LUER LOCK AND THE TUBING CONNECTED TO THE IPR BAG. ADDITIONALLY, ON (B)(6) 2017 A PHARMACIST FOUND THE LEAK BEFORE GIVEN TO PATIENT, NO 5FU WITH THIS ONE SO THERE WAS NO POSSIBLE CHEMICAL EXPOSURE. NO INJURIES TO PATIENT OR STAFF.