MalfunctionFKB
SMITHS MEDICAL MEDEX HIGH PRESSURE TUBING
Received Oct 15, 2019 · Event occurred Oct 2, 2019
Report 3012307300-2019-05751 · MDR key 9194167
Device
Generic name
Connector, Blood Tubing, Infusion T
Manufacturer
Smiths Medical Asd, Inc.Catalog number
MX693P1CZ
Product problems
- Leak/Splash
- Inadequate User Interface
- Leak/Splash
- Inadequate User Interface
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER INDICTING THE CAUSE OF FAULT WAS DUE TO A HANDLING ISSUE AND THAT THERE WAS NO PRODUCT PROBLEM.
Description of Event or Problem
INFORMATION WAS RECEIVED STATING SMITHS MEDICAL MEDEX HIGH PRESSURE TUBING HAS FAILED, DISPERSING BLOOD/FLUID. NO ADVERSE EFFECTS REPORTED.