MalfunctionFEN
RUSCH TWIN LUMEN
Received Sep 18, 2001
Report 8010092-2001-00167 · MDR key 352518
Device
Generic name
Urodynamic Catheter
Manufacturer
Rusch Manufacturing UkModel number
NACatalog number
580512
Lot number
*
Product problems
- Restricted Flow rate
- Inadequacy of Device Shape and/or Size
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE CUSTOMER REPORTS THAT THE FILL CHANNEL IS TOO SMALL AND IT IS TAKING A LONG TIME TO FILL.