NRFIT
Received Oct 13, 2020
Report 3012307300-2020-10295 · MDR key 10670329
Device
Generic name
Administrations Sets With Neuraxial Connectors Int
Manufacturer
Smiths Medical Asd, Inc.Model number
21-7609-24Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
OTHER, OTHER TEXT: ONE SAMPLE WAS RECEIVED FOR EVALUATION. DEVICE UNDERWENT FUNCTIONAL TESTING. A LEAK WAS DETECTED, CONFIRMING THE REPORTED CUSTOMER COMPLAINT. THE PROBLEM SOURCE HAS BEEN DETERMINED TO BE MANUFACTURING. ADDITIONALLY, TWO PICTURES WERE RECEIVED FOR EVALUATION. THERE WAS NO EVIDENCE OF DAMAGE THAT COULD CREATE THE FAILURE MODE REPORTED.
Additional Manufacturer Narrative
CUSTOMER FACILITY PHONE NUMBER: (B)(6).
Description of Event or Problem
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PRODUCT WAS NOTED TO HAVE MEDIAL FLUID LEAKING FROM THE PART TO WHICH A TUBING WAS CONNECTED. THERE WAS NO PATIENT INJURY. THERE WERE NO REPORTED ADVERSE EVENTS.