NIPRO BLOODLINE
Received Oct 25, 2006 · Event occurred Oct 19, 2006
Report 2316883-2006-00002 · MDR key 919469
Device
Generic name
Blood Tubing Set For Dialysis
Manufacturer
Nipro Medical CorporationModel number
A209/V803Catalog number
A209V*03
Lot number
06D05
Product problems
- Restricted Flow rate
- Kinked
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
REPORTERS REPORTED THAT SOME OF THE NIPRO BLOOD LINES THAT THEY HAD RECEIVED HAD A KINK IN THE TUBING. INITIALLY, THE PROBLEM WAS THOUGHT TO BE COSMETIC IN NATURE WITH NO EFFECT ON PERFORMANCE. FURTHER COMPLAINTS WERE MADE THAT THE KINK "INHIBITS PROPER FLOW AND CAUSES COMPLICATIONS DURING DIALYSIS." THE VENOUS LINE OF AN UNUSED SET IS BEING HELD FOR PICKUP, AND RETURN TO NIPRO MEDICAL CORPORATION FOR EVALUATION.