PORTEX GENERAL ANESTHESIA SODASORB CO2 ABSORBENT
Received Sep 16, 2022 · Event occurred Jun 10, 2020
Report 3012307300-2022-19378 · MDR key 15436710
Device
Generic name
Absorbent, Carbon-dioxide
Manufacturer
Smiths Medical International, Ltd.Catalog number
8870
Product problems
- Crack
- Crack
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. INITIAL REPORTER ALSO SENT REPORT TO FDA IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. PREMARKET (510K) NUMBER IS UNKNOWN. NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. 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. 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 A CANNISTER WITHIN THE CASE WAS CRACKED UPON ARRIVAL AND POWDERY SUBSTANCE WAS LEAKING OUT OF THE CANISTER. NO PATIENT INJURY WAS REPORTED.