OtherMOU
ALPHA IV REV. 2 40MM ACTIVE TRANSFER
Received Feb 6, 2004 · Event occurred Jan 6, 2004
Report 1062385-2004-00001 · MDR key 518762
Device
Generic name
Transfer Device
Manufacturer
Novoste Corp.Model number
A1733Catalog number
TDA-0040
Lot number
NA
Product problems
- Mislabeled
Patient
*
Narrative
Description of Event or Problem
THE TRANSFER DEVICE SERIAL # ON THE CALIBRATION CERTIFICATE DID NOT MATCH THE SERIAL # OF THE TRANSFER DEVICE THAT WAS RECEIVED AT THE SITE. THE MISTAKE WAS IDENTIFIED BY THE CUSTOMER DURING THE RECEIVING QA PROCEDURES ESTABLISHED FOR HANDLING RADIOACTIVE MATERIALS. THE TRANSFER DEVICE WAS NOT USED.
Remedial action
- Relabeling