BOLSA VACIA 3L EVA TRES VIAS DE TRANSFERENCIA CON DESCONEXIO

Description of Event or Problem

THE CUSTOMER REPORTED TO BAXTER (B)(4) OF ONE EVA 3L EMPTY BAG IN WHICH ONE OF THE TUBES FELT OFF DURING THE USE. THE SAMPLE IS AVAILABLE. PATIENT INJURY AND MEDICAL INTERVENTION WERE NOT REPORTED FOR THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

(B)(4). THE ACTUAL SAMPLE WAS EVALUATED WITH VISUAL INSPECTION AND LEAK TEST. THE BAG LEAK WAS DETERMINED TO BE AT THE SEAL OF THE PORT AND BAG. THE LEAK WAS CAUSED BY THE WEARING OUT OF THE SEALING APPARATUS ON THE BAG ASSEMBLY EQUIPMENT. AS CORRECTIVE ACTIONS, THE SEALING APPARATUS WAS REPLACED ON THE MACHINE AND A SUCCESSFUL LEAK TEST WAS PERFORMED ON THE PRODUCT. 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.