VIASYS
Received Mar 12, 2010 · Event occurred Feb 10, 2010
Report 2021710-2010-00008 · MDR key 1631197
Device
Generic name
Byp Mouthpiece, Breathing
Manufacturer
CarefusionModel number
MOUTHPIECES, LARGECatalog number
42157
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
65 YR
- Bleeding
Narrative
Additional Manufacturer Narrative
THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. (B)(4): SAMPLES OF THE ALLEGED FAULTY DEVICE WERE RECEIVED ON (B)(4) 2010 AND WERE ROUTED INTO THE CAREFUSION FAILURE ANALYSIS LAB AND ARE IN THE QUEUE AWAITING EVALUATION.
Description of Event or Problem
THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH USER FACILITY REPRESENTATIVE. "[NAME REMOVED] HAS USED THESE MOUTHPIECES FOR A LONG TIME. THE PAST THREE ORDERS HE HAS NOTICED THAT THEY ARE CUT INCORRECTLY AND MISSING MUCH OF THE MYLAR COATING OF THE MOUTHPIECE. HE STATES ABOUT TEN PATIENTS BETWEEN THE AGES OF (B)(6 HAVE ENDED UP WITH BLOODY LIPS AFTER REMOVING THEIR LIPS FROM THE MOUTHPIECE. THIS INCLUDES HIMSELF WHICH HE IS THE BIOLOGICAL STANDARD FOR THE LAB. HE IS USING A MEDGRAPHICS SYSTEM, BUT ORDERS MOUTHPIECES FROM US."