GPS III SINGLE KIT W/30ML ACDA
Received Jan 18, 2012 · Event occurred Dec 19, 2011
Report 0001825034-2012-00061 · MDR key 2420597
Device
Generic name
Supplies, Blood Bank
Manufacturer
Biomet BiologicsModel number
N/ACatalog number
800-1003A
Lot number
112953
Product problems
- Hole In Material
- Leak/Splash
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2011, PATIENT'S BLOOD WAS PLACED IN A PLATELET CONCENTRATION KIT. AS THE BLOOD WAS PUT INTO THE CYLINDER, THE BLOOD STARTED TO BE EXPELLED OUT THE TOP OF THE CYLINDER. UPON INSPECTION OF THE CYLINDER, IT WAS NOTED THAT THERE WAS A HOLE ON THE TOP OF THE CYLINDER WHERE A FILTER IS USUALLY LOCATED.
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF RECEIVING CERTIFICATE OF CONFORMANCE SHOWED THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF DEVICE SALES HISTORY SHOWS EIGHT DEVICES CONFIRMED USED WITH NO REPORTED COMPLICATIONS.