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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS ANESTHESIA CONDUCTION KIT

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AVANOS MEDICAL, INC. AVANOS ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 181A321
Device Problems Contamination /Decontamination Problem (2895); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  malfunction  
Event Description
Small piece of unknown debris found within a depression of a "universal block tray". Tray and sterile field replaced, "contaminated tray" removed, photographed and particle attached to the packaging from which it was removed. Product name: universal block tray. Tray and contents discarded; saved outer packaging and unknown debris (taped to packaging).
 
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Brand NameAVANOS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key12066205
MDR Text Key258364005
Report Number12066205
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 06/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number181A321
Device Catalogue Number181A321
Device Lot Number30114617
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2021
Event Location Hospital
Date Report to Manufacturer06/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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