CYSTOFLO BAGS
Received Oct 7, 2010 · Event occurred Sep 14, 2010
Report 6000001-2010-03830 · MDR key 1859990
Device
Generic name
Bag, Reservoir
Manufacturer
Baxter Healthcare - CaliCatalog number
MRD2926
Lot number
SX09KD3
Product problems
- Material Rupture
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A CYSTOFLO BAG WITH A RUPTURE IN THE BAG. THE CONDITION WAS REPORTED BEFORE USE. 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 AND THE ISSUE WAS CONFIRMED. IN THE SAMPLE EVALUATION AN EXCESS OF SOLVENT BETWEEN THE DRAINAGE TUBE AND THE BAG WAS OBSERVED. IT WAS DETERMINED THAT THE INTERNAL BAG IS BROKEN BY THE PRESENCE OF SOLVENT IN THE BODY OF THE BAG. NO CORRECTIVE ACTION WAS PERFORMED. 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.