CAPIOX BUBBLE TRAPS
Received Jun 10, 2010 · Event occurred May 12, 2010
Report 9681834-2010-00051 · MDR key 2581444
Device
Generic name
Bubble Trap
Manufacturer
Terumo Corporation, AshitakaModel number
NACatalog number
XX*XH041
Lot number
NA
Product problems
- Break
Patient
UNK
- No Patient involvement
Narrative
Additional Manufacturer Narrative
THE ACTUAL DEVICE WAS NOT RETURNED TO TERUMO FOR EVAL. A REVIEW OF THE DHR OF THE INVOLVED PRODUCT CODE FOR THE PERIOD OF THE PAST THREE YEARS CONFIRMED THERE WERE NO INDICATIONS OF PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THERE HAVE BEEN NO PREVIOUS REPORTS FOR THIS PRODUCT CODE. WITH NO LOT NUMBER INFO, THE MFG DATE OF THE ACTUAL DEVICE WAS UNTRACEABLE. THE EXPIRATION OF THIS PRODUCT CODE IS NOT ESTABLISHED DUE TO THE PRODUCT NATURE. THE CAUSE OF THIS EVENT CANNOT BE DETERMINED DUE TO THE ABSENCE OF THE ACTUAL DEVICE AND LOT NUMBER. (B)(4).
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING SET-UP, THE HOLDER FOR THE BUBBLE TRAP BROKE. THE PRODUCT WAS CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.