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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL EPIDURAL TRAY ANESTHESIA CONDUCTION TRAY

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SMITHS MEDICAL EPIDURAL TRAY ANESTHESIA CONDUCTION TRAY Back to Search Results
Model Number A3195-17
Device Problem Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/26/2017
Event Type  malfunction  
Event Description
With regard smiths medical continuous epidural tray - after epidural space is acquired with touhy needle, it is found to sometimes be difficult/impossible to pass the catheter through the touhy needle. On inspection, it was found that catheter would catch at the tip of the needle, when it should pass easily through the tip. In addition, the catheter cannot pass at all through the after market 6" touhy needle.
 
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Brand NameEPIDURAL TRAY
Type of DeviceANESTHESIA CONDUCTION TRAY
Manufacturer (Section D)
SMITHS MEDICAL
plymouth MN 55442
MDR Report Key7171550
MDR Text Key96729070
Report NumberMW5074446
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2019
Device Model NumberA3195-17
Device Lot Number3530885
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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