MAUDE Adverse Event Report:; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 07/16/2010

Event Type  malfunction  

Event Description

Epidural catheter was being removed from pediatric patient following surgery.In process of removing the sutures holding the catheter in place, the catheter was cut and approximately 7.5 cm remained in patient.This retained piece was removed two days later and patient was not injured.Health professional's impression: was inadvertently cut by physician during removal.

• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• MDR Report Key: 7381580
• MDR Text Key: 103988498
• Report Number: 7381580
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2010,02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2010
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2010
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR