MalfunctionGCD
PLUREVAC THORACIC TROCAR CATH 20FR SOFT 10/BX
Received Apr 2, 2010 · Event occurred Feb 3, 2012
Report 3004365956-2012-00138 · MDR key 2546837
Device
Product problems
- Positioning Failure
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE EVENT IS REPORTED AS: PER MAUDE REPORT: ATTEMPT TO PLACE #20 TROCAR CHEST TUBE TWICE, PRODUCT TIP WOULD NOT ALLOW SURGEON TO SUCCESSFULLY PLACE TUBE. NO PT INJURY REPORTED.
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. NO CORRECTIVE ACTION CAN BE ESTABLISHED SINCE NO SAMPLE WAS PROVIDED, LOT NUMBER IS NOT AVAILABLE FOR A DEEPER INVESTIGATION. COMPLAINT CANNOT BE CONFIRMED SINCE NO EVIDENCE COULD BE GATHERED IN ORDER TO EVALUATE THIS INCIDENT, LOT NUMBER OF THE INVOLVED PRODUCT COULD NOT BE PROVIDED EITHER.