MalfunctionGBT
RUSCH
Received Jan 17, 2002
Report 8040412-2002-00012 · MDR key 372940
Device
Generic name
St. Bartholomew Catheter
Manufacturer
Rusch Sdn. Bhd.Model number
NACatalog number
264030
Lot number
97NSI1
Product problems
- Balloon burst
Patient
UNKNOWN
- No Consequences Or Impact To Patient
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE CUSTOMER REPORTS THAT THE BALLOON BUSTED.