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U.S. Department of Health and Human Services

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

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HALYARD HEALTH, INC. HALYARD ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 99944
Device Problem Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/21/2018
Event Type  malfunction  
Event Description
Anesthesia found an epidural nerve block tray with a hair in the tray. Kimberly clark # 181a343. Lot# 0202966554.
 
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Brand NameHALYARD
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
HALYARD HEALTH, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key7946424
MDR Text Key123075783
Report Number7946424
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 09/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number99944
Device Catalogue Number181A343
Device Lot Number0202966554
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 FDA09/26/2018
Event Location Hospital
Date Report to Manufacturer10/09/2018
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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