MalfunctionCBL
ANESTHESIA SODASORB CO2 ABSORBENT
Received Sep 14, 2022
Report 3012307300-2022-19061 · MDR key 15416985
Device
Generic name
Absorbent, Carbon-dioxide
Manufacturer
Smiths Medical International, Ltd.Catalog number
8870
Product problems
- Device Damaged Prior to Use
- Device Damaged Prior to Use
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE ITEM WAS DAMAGED WHEN CUSTOMER RECEIVED. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD (DHR) IS AT THE SUPPLIER. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION AT THE SUPPLIER. THE ROOT CAUSE IS UNKNOWN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# ()(4).