MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-17019-SM

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported by fda medwatch # (b)(4).The epidural was placed by certified registered nurse anesthetist (crna).Once the epidural catheter was in place, the catheter was not patent and unable to be flushed or have test dose administered.Connector changed by crna and there was still no success in flushing the epidural catheter.Epidural catheter was removed and there were no kinks or knots noted in the catheter.A new catheter was then placed and flushed successfully.The patient was not harmed and had a functional epidural on the second attempt.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of the catheter being blocked could not be determined based upon the information provided and without a sample.

Event Description

Reported by fda medwatch (b)(4).The epidural was placed by certified registered nurse anesthetist (crna).Once the epidural catheter was in place, the catheter was not patent and unable to be flushed or have test dose administered.Connector changed by crna and there was still no success in flushing the epidural catheter.Epidural catheter was removed and there were no kinks or knots noted in the catheter.A new catheter was then placed and flushed successfully.The patient was not harmed and had a functional epidural on the second attempt.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10270167
• MDR Text Key: 198734405
• Report Number: 1036844-2020-00208
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: ASK-17019-SM
• Device Lot Number: 23F20A0358
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention