BOLSA EVA PARENTERAL 2000MLEN PEEL POUCH

Description of Event or Problem

THE CUSTOMER REPORTED TO BAXTER (B)(4) OF AN EVA PARENTERAL BAG WITH A LEAK IN THE FILLING PORT JOINT. 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 DEFECT WAS CONFIRMED AND DETERMINED TO BE A LEAK AT THE PORT TUBE SEAL. THE INCORRECT SEALING WAS PROVOKED BY WEAR OUT OF THE SEALING PIECES. IN ORDER TO AVOID THIS, THE SEALING PIECES WERE REPLACED ON THE MACHINE AND A LEAK TEST WITH WATER WAS IMPLEMENTED. 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.