CADD CASSETTE RESERVOIR
Received Oct 29, 2020 · Event occurred Oct 1, 2020
Report 3012307300-2020-10795 · MDR key 10757225
Device
Generic name
Set, Administration, Intravascular
Manufacturer
Smiths Medical Asd, Inc.Model number
21-7600-24Catalog number
21-7600-24
Lot number
3883724
Product 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: DEVICE EVALUATION- TWO USED SAMPLES AND FOURTEEN UNUSED SAMPLES WERE RETURNED FOR EVALUATION. THE DEVICE WAS GIVEN FUNCTIONAL TESTING: ALL WERE FOUND TO FUNCTION WITH NO LEAKAGE DETECTED. THE REPORTED ISSUE WAS NOT CONFIRMED.
Description of Event or Problem
INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY AFTER STARTING TO USE A SMITHS MEDICAL CADD CASSETTE RESERVOIR, THE CUSTOMER NOTICED MEDICAL FLUID WAS LEAKING FROM THE PART WHERE THE CONNECTOR AND THE TUBING WERE CONNECTED. THERE WAS NO PATIENT INJURY.