MalfunctionFPK
MICROBORE EXTENSION SET, 60IN
Received Oct 19, 2016
Report 9612030-2016-00532 · MDR key 6041878
Device
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH AN EXTENSION SET. THE CUSTOMER REPORTS THAT THE TUBE WAS LEAKING AT THE INSERTION SITE WHERE THE PURPLE PIECE CONNECTS TO THE TUBING.