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

Catalog Number EC-05000

Device Problems Material Separation (1562); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2019

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

Received via medwatch# (b)(4).It was reported that there were 2 catheters which are defective: one was bent and the second one shredded.

Manufacturer Narrative

(b)(4).The customer reported the catheter was bent.The customer returned one epidural catheter w/stylet and packaging (reference files inp 1900075327).The returned catheter was visually examined with and without magnification.Visual examination of the returned catheter revealed the catheter's distal tip is bent.The tip is still intact (reference files anp1900075327).No other defects or anomalies were observed.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 the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of the catheter being bent was confirmed based on the sample received.During visual inspection, it was observed the distal tip of the returned catheter was bent.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.It is unknown how the catheter was handled prior to and during use.Therefore, the potential cause of the catheter being bent could not be determined.

Event Description

Received via medwatch# 4900240000-2020-8002.It was reported that there were 2 catheters which are defective: one was bent and the second one shredded.

• Brand Name: EPIDURAL CATHETERIZATION COMPONENT
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9693989
• MDR Text Key: 179411057
• Report Number: 1036844-2020-00062
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K801912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: EC-05000
• Device Lot Number: 13F18C0518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• 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
• Treatment: N/A.
• Patient Age: 56 YR
• Patient Weight: 111