MEDEX EXTENSION SETS SINGLE
Received Oct 13, 2022 · Event occurred Jun 16, 2021
Report 3012307300-2022-20027 · MDR key 15595390
Device
Generic name
Tubing, Fluid Delivery
Manufacturer
Smiths Medical Asd, Inc.Model number
MX448HLCatalog number
MX448HL
Product problems
- Defective Device
- Defective Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. SAMPLE WAS TESTED FOR FUNCTIONALITY WITH WATER, FLUID WOULD NOT FLOW THROUGH DEVICE AND COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE RELATED TO THE EXTRUSION PROCESS OF THE TUBING. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS#: 617147.
Description of Event or Problem
IT WAS REPORTED THAT FLUID WOULD NOT FLOW THROUGH TUBING WHEN ADMINISTERING FLUID OR MEDICATION. NO PATIENT INJURY WAS REPORTED.