EVA BAG-500ML
Received Oct 7, 2010 · Event occurred Aug 31, 2010
Report 6000001-2010-03827 · MDR key 1859976
Device
Generic name
Bag, Reservoir
Manufacturer
Baxter Healthcare - Sao PauloCatalog number
AZB8152
Lot number
PE28N1
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED TO BAXTER (B)(4) AN EVA BAG THAT PRESENTED A LEAK. THE CONDITION OCCURRED DURING FILLING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
(B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. THE BATCH REVIEW WAS COMPLETED FOR THE REPORTED LOT AND NO DEVIATIONS WERE FOUND. 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.