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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL SODASORB; ABSORBENT, CARBON-DIOXIDE
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NULL SODASORB; ABSORBENT, CARBON-DIOXIDE Back to Search Results
Catalog Number 008875
Device Problem Material Discolored (1170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/1901
Event Type  malfunction  
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).
 
Event Description
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.
 
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Brand Name
SODASORB
Type of Device
ABSORBENT, CARBON-DIOXIDE
Manufacturer (Section G)
NULL
MDR Report Key15445177
MDR Text Key306160931
Report Number3012307300-2022-19591
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 09/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number008875
Device Lot NumberCH10 P12807
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/11/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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