MAUDE Adverse Event Report: EPIMED BREVI-XL/2 RADIO-OPAQUE EPIDURAL CATHETER; EPIMED CATHETER

Model Number 155-2342

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/09/2016

Event Type  Injury  

Event Description

Part of epimed catheter was retained in patient.Catheter was placed into the epidural space for steroid infusion over 72 hours.Patient went home with the catheter in place and left it in for 4 days.It was pulled by lay person on the 4th day and the tip of the catheter was retained in the patient.

• Brand Name: BREVI-XL/2 RADIO-OPAQUE EPIDURAL CATHETER
• Type of Device: EPIMED CATHETER
• Manufacturer (Section D): EPIMED; johnstown NY
• MDR Report Key: 5678254
• MDR Text Key: 45964993
• Report Number: MW5062461
• 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: Physician
• Type of Report: Initial
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Model Number: 155-2342
• Device Catalogue Number: 155-2342
• Device Lot Number: 11937015
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Weight: 88