MAUDE Adverse Event Report: TELEFLEX INCORPORATED THERACATH EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Catalog Number AK-05000

Patient Problem Insufficient Information (4580)

Event Date 09/15/2023

Event Type  malfunction  

Event Description

The kit only had 1 drape: the drape that was missing was the one with the circular opening, which allows the doctors to perform the procedure near the neck area.

• Brand Name: THERACATH EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 17867861
• MDR Text Key: 324909083
• Report Number: 17867861
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AK-05000
• Device Lot Number: 33F23D0507
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1