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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 39204
Device Problem Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 01/11/2022
Event Type  malfunction  
Event Description
The 4in echobrite needle system used for nerve blocks leaked at an area just proximal of the needle and distal of the connection point.This allowed the nerve block medication to leak when pressure was applied.It was not evident when flushing of the line and only occurred when the needle was in the patient.
 
Event Description
The 4in echobrite needle system used for nerve blocks leaked at an area just proximal of the needle and distal of the connection point.This allowed the nerve block medication to leak when pressure was applied.It was not evident when flushing of the line and only occurred when the needle was in the patient.
 
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Brand Name
AVANOS
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key13497310
MDR Text Key285334114
Report Number13497310
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00193494392048
UDI-Public(01)00193494392048
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number39204
Device Catalogue NumberEBL20100SG
Device Lot Number30139427
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/2022
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer02/09/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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