MEDEX EXTENSION SETS MULTI LINE
Received Dec 29, 2022 · Event occurred Nov 8, 2022
Report 3012307300-2022-28303 · MDR key 16074945
Device
Generic name
Intravascular Administration Set
Manufacturer
Smiths Medical International, Ltd.Catalog number
MX618CZ
Lot number
4306091
Product problems
- Flushing Problem
- Flushing Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE CHECK VALVES WHEN TRYING TO FLUSH TWO OF THESE LINES AND ONLY TWO OF THE LUMENS WERE NOT FLUSHABLE, THE THIRD SET WORKED FINE. THE LINE WAS GOING TO BE USED ON A PATIENT HOWEVER THEY FOUND THE LINE WOULDN'T FLUSH SO IT WAS REMOVED BEFORE USE.
Additional Manufacturer Narrative
H6. HEALTH IMPACT AND EVALUATION CODES: UPDATED. NO PRODUCT WAS RETURNED THEREFORE AN INVESTIGATION COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD (DHR) REVIEW SHOWED THERE WERE NO OBSERVATIONS RECORDED DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER. THIS ISSUE WILL CONTINUE TO BE MONITORED AND FURTHER ACTIONS TAKEN ACCORDINGLY. IF THE DEVICE IS RETURNED THE MANUFACTURER WILL RE-OPEN THE INVESTIGATION.