MalfunctionLIO
UROLEX
Received Mar 31, 2011 · Event occurred Mar 30, 2011
Report 2048113 · MDR key 2048113
Device
Generic name
Sterile Specimen Container
Manufacturer
CarefusionModel number
01053Catalog number
*
Lot number
H362010530Z
Product problems
- Device Contamination with Chemical or Other Material
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BLACK DEBRIS WAS OBSERVED IN BOTTOM OF THE SPECIMEN CONTAINER CUP WHEN STERILE WATER WAS POURED. THIS WAS NOTICED DURING A CASE SET UP. THERE WAS NO PATIENT IMPACT.==== REPORTER'S RESPONSES ======REPORTER INDICATED THEY DID NOT HAVE SIMILAR PROBLEMS BEFORE. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. LOT NUMBER WAS UNKNOWN.