GPS III KIT
Received May 25, 2012 · Event occurred May 10, 2012
Report 0001825034-2012-00683 · MDR key 2589213
Device
Generic name
Hematology Product
Manufacturer
Biomet BiologicsModel number
N/ACatalog number
800-0505A
Lot number
112904
Product problems
- Chemical Spillage
Patient
Not reported
- Erythema
- Irritation
- Chemical Exposure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED UTILIZING A PLATELET SEPARATION SYSTEM ON (B)(6), 2012. AS THE TECHNICIAN WAS TRYING TO REMOVE AIR FROM THE SYRINGE CONTAINING THE ACD-A SOLUTION, THE SOLUTION DISCHARGED INTO HER EYES. THE TECHNICIAN FLUSHED HER EYES WITH WATER FOR TEN MINUTES, BUT EXPERIENCED REDNESS AND IRRITATION THROUGHOUT THE FOLLOWING DAY.
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. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1216032-2012-00001).