MAUDE Adverse Event Report: TELEFLEX MEDICAL / ARROW INTERNATIONAL INC. THERACATH EPIDURAL CATHETER; ANESTHESIA CONDUCTION KIT

Model Number EC-05000

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/26/2019

Event Type  Injury  

Event Description

Retained epidural catheter in right thigh from pain pump required surgical intervention to remove.Fda safety report id# (b)(4).

• Brand Name: THERACATH EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX MEDICAL / ARROW INTERNATIONAL INC. ; reading PA 19605
• MDR Report Key: 9526084
• MDR Text Key: 173180966
• Report Number: MW5091919
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EC-05000
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR