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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. ANESTHESIA SODASORB CO2 ABSORBENT; ABSORBENT, CARBON-DIOXIDE
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SMITHS MEDICAL INTERNATIONAL, LTD. ANESTHESIA SODASORB CO2 ABSORBENT; ABSORBENT, CARBON-DIOXIDE Back to Search Results
Catalog Number 8870
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the item was damaged when customer received.No patient injury was reported.
 
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).
 
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Brand Name
ANESTHESIA SODASORB CO2 ABSORBENT
Type of Device
ABSORBENT, CARBON-DIOXIDE
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK   CT21 6JL
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15416985
MDR Text Key306258504
Report Number3012307300-2022-19061
Device Sequence Number1
Product Code CBL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number8870
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/09/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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