MalfunctionFPK
MEDEX
Received Aug 6, 2021 · Event occurred Jun 29, 2021
Report 3012307300-2021-08159 · MDR key 12291271
Device
Generic name
Intravenous Extension Tubing Set
Manufacturer
Smiths Medical Asd, Inc.Model number
MX450FLLot number
4072121
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE END OF THE DEVICE HAS PULLED OFF MULTIPLE TIMES CAUSING FLUID INCLUDING BLOOD TO BE LOST.