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

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.

• Brand Name: EPIDURAL TRAY
• Type of Device: ANESTHESIA CONDUCTION TRAY
• Manufacturer (Section D): SMITHS MEDICAL; plymouth MN 55442
• MDR Report Key: 7171550
• MDR Text Key: 96729070
• Report Number: MW5074446
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: A3195-17
• Device Lot Number: 3530885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 72