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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 39224
Device Problems Difficult to Insert (1316); Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2018
Event Type  malfunction  
Event Description
During pain block procedure,the physician was unable to thread the catheter through the needle after the correct anatomical site had been reached for the paravertebral block on the right back. The needle was withdrawn and another needle was inserted. The physician was able to successfully thread the catheter with the second needle. Upon inspection of the needle, the top of the needle was actually in the hub, so that the catheter would not thread. There was no known injury to the patient.
 
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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 Key7681367
MDR Text Key113802454
Report Number7681367
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 06/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number39224
Device Catalogue NumberELL18100TG
Device Lot Number020836078
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 FDA06/12/2018
Event Location Hospital
Date Report to Manufacturer07/12/2018
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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