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U.S. Department of Health and Human Services

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

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AVANOS MEDICAL, INC. HALYARD ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 99947
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 03/28/2019
Event Type  malfunction  
Event Description
Sterile pack. Upon opening, found hair within pack. Considered unsterile and not used for patient care. Another sterile pack obtained.
 
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Brand NameHALYARD
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key8526694
MDR Text Key142337819
Report Number8526694
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number99947
Device Catalogue Number181A345
Device Lot Number0203086871
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/04/2019
Event Location Hospital
Date Report to Manufacturer04/18/2019
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

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