MEDEX EXTENSION SETS SINGLE LINE
Received Jun 22, 2021 · Event occurred May 22, 2021
Report 3012307300-2021-06392 · MDR key 12043140
Device
Generic name
Tubing, Fluid Delivery
Manufacturer
Smiths Medical Asd, Inc.Model number
MX458LCatalog number
MX458L
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EXTENSION SET WAS FLUSHED AND A LEAK WAS NOTED FROM TRIFUSE IV EXTENSION TUBING (PRODUCT NEW FROM PACKAGING, WITHIN 30 MINS OF EVENT). THERE WERE NO REPORTED ADVERSE EVENTS.