MalfunctionMOU
ALPHAIV REV2, 40MM ACTIVE TRANSFER DEVICE
Received Oct 25, 2002 · Event occurred Oct 22, 2002
Report 1062385-2002-00037 · MDR key 424639
Device
Generic name
Transfer Device
Manufacturer
Novoste Corp.Model number
A1733Catalog number
WLC-0001-042
Lot number
NA
Product problems
- Spillage, accidental
- Cut In Material
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE 5F 40MM BETA-CATH CATHETER FOR THE 5F 40MM TRANSFER DEVICE WAS CUT, RESULTING IN 16 ACTIVE SOURCES BEING RELEASED INTO THE BAIL OUT BOX. ALL ACTIVE SOURCES WERE POSITIVELY ACCOUNTED FOR BY THE SITE. NO ADVERSE EVENT OR PT INJURY WAS REPORTED.