MalfunctionFPK
MICROBORE EXTENSION SET, 60IN
Received Oct 19, 2016 · Event occurred Oct 14, 2016
Report 9612030-2016-00535 · MDR key 6041940
Product problems
- Material Twisted/Bent
- No Flow
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 10/14/2016 THAT A CUSTOMER HAD AN ISSUE WITH AN EXTENSION SET. THE CUSTOMER REPORTS THAT THE EXTENSION SET IS BONDED TOGETHER AND WILL NOT ALLOW FLUIDS TO PASS.