MalfunctionOGJ
ARROW FLEXBLOCK KIT: ECHO CATH, 17GX8CM STM NDL
Received Sep 24, 2014 · Event occurred Sep 1, 2014
Report 1036844-2014-00383 · MDR key 4142694
Device
Product problems
- Break
- Material Fragmentation
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.
Description of Event or Problem
THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE LIDOCAINE VIAL SHATTERED UPON BREAKING AT THE SCORELINE. NO PATIENT/USER INJURY REPORTED.