3L DUAL EVA BAG

Description of Event or Problem

THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A 3L DUAL EVA BAG THAT WAS LEAKING FROM THE MIDDLE PORT CONNECTION PART OF THE BAG. THE CONDITION WAS DISCOVERED BEFORE USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THE REPORTED CONDITION OF LEAKING FROM THE MIDDLE PORT CONNECTION PART OF THE BAG WAS CONFIRMED. THE BAG WAS INFLATED WITH AIR AND LEAK TESTED UNDER WATER. A LEAK WAS REVEALED FROM A VERY TINY SLIT IN THE BAG NEXT TO THE MIDDLE PORT. THE ROOT CAUSE FOR THE SLIT IN BAG COULD NOT BE DETERMINED. BATCH FILE REVIEW WAS PERFORMED AND DID NOT REVEAL ANY ISSUES RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

Additional Manufacturer Narrative

(B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.