MAUDE Adverse Event Report: EPIDURAL CATHETER; CATHETER, CONDUCTION, ANESTHETIC

Lot Number 0061757643

Device Problem Stretched (1601)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2021

Event Type  malfunction  

Event Description

Upon removal of epidural catheter noticed that the catheter appeared to be stretched thin and stopped attempted removal.The catheter was removed by the surgeon.Fda safety report id# (b)(4).

• Brand Name: EPIDURAL CATHETER
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• MDR Report Key: 11760795
• MDR Text Key: 249003036
• Report Number: MW5101132
• Device Sequence Number: 1
• Product Code: BSO
• 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: 04/29/2021

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: No Information
• Device Lot Number: 0061757643
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 68