SODASORB
Received Sep 19, 2022 · Event occurred Jan 1, 1901
Report 3012307300-2022-19591 · MDR key 15445177
Device
Generic name
Absorbent, Carbon-dioxide
Catalog number
008875
Lot number
CH10 P12807
Product problems
- Material Discolored
- Material Discolored
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 INSPECTION WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. THIS ISSUE HAS HAPPENED BEFORE IN THE PAST AND IS A RARE OCCURRENCE. THERE IS NO ROOT CAUSE CAN BE PROVIDED A THIS TIME. DEVICE INFORMATION UDI UNKNOWN, OPERATOR OF DEVICE IS UNKNOWN, REPORT SOURCE IS UNKNOWN, PROTOCOL # IS UNKNOWN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE CONTENTS HAVE CHANGED COLOR TO LIGHT PURPLE AND HAVE HAS NOT BEEN EXPOSED TO GAS. NO PATIENT INJURY WAS REPORTED.