GPS III PLATELET CONCENTRATE SEPARATION KIT/SINGLE DISPOSABLE 30ML ACD-A
Received Aug 14, 2012 · Event occurred Jun 18, 2012
Report 0001825034-2012-01281 · MDR key 2696149
Device
Generic name
Supplies, Blood-bank
Manufacturer
Biomet BiologicsModel number
N/ACatalog number
800-0505A
Lot number
200802
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED PATIENT UNDERWENT A PLANTAR FASCIA INJECTION ON (B)(6) 2012. DURING THE PROCEDURE, A GPS MINI KIT WAS OPENED AND THE BUOY WAS ELEVATED FROM THE NORMAL POSITION AT THE BASE OF THE GPS TUBE PRIOR TO CENTRIFUGATION. ANOTHER KIT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR SURGICAL DELAY OCCURRED.
Additional Manufacturer Narrative
EXAMINATION OF RETURNED DEVICE WAS INCONCLUSIVE. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE USER FACILITY WAS NOTIFIED OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA.