MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT: 19 GA

Catalog Number ASK-05500-JHH1

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient was admitted to labor and delivery.An epidural catheter was being placed in preparation for a planned c-section.The tough needle was placed.Upon attempting to thread the catheter, at approximately 2 cm into the tough needle, resistance was felt.Re-threading of catheter was attempted, but was unsuccessful when resistance was again felt at 2 cm.Upon removing the catheter from the needle, approximately 5mm of circular metal fragments were noted.The fragments looked similar to circular pencil sharpener shavings, but were naturally much smaller.A new epidural catheter kit was opened, and the epidural was easily inserted.The tip of the original tough introducer needle was intact, as was the catheter they attempted to thread.Since the team was not certain whether any metal fragments had been pushed into the patient and retained under the skin, they obtained an x-ray following delivery, with the consent of the patient, to ensure no metal fragments were present.

Manufacturer Narrative

Qn#(b)(4).A review of design change history for kit ask-05500-jhh1, part number l-05000-007, and kz-05400-021 was performed as a part of this investigation.No design changes have been made to this product in the past two years that would have led to this complaint.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 and needle with no relevant findings.The potential cause of catheter not advancing could not be determined based upon the information provided and without a sample.

Event Description

The patient was admitted to labor and delivery.An epidural catheter was beingplaced in preparation for a planned c-section.The toughy needle was placed.Upon attempting to thread the catheter, at approximately 2 cm into the toughy needle, resistance was felt.Re-threading of catheter was attempted, but was unsuccessful when resistance was again felt at 2 cm.Upon removing the catheter from the needle, approximately 5mm of circular metal fragments were noted.The fragments looked similar to circular pencil sharpener shavings, but were naturally much smaller.A new epidural catheter kit was opened, and the epidural was easily inserted.The tip of the original toughy introducer needle was intact, as was the catheter they attempted to thread.Since the team was not certain whether any metal fragments had been pushed into the patient and retained under the skin, they obtained an x-ray following delivery, with the consent of the patient, to ensure no metal fragments were present.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA
• MDR Report Key: 10719406
• MDR Text Key: 214800670
• Report Number: 1036844-2020-00260
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: ASK-05500-JHH1
• Device Lot Number: 23F20D0344
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2020
• 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