MAUDE Adverse Event Report: EPIMED INTERNATIONAL, INC. BREVI STF; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number 155-2343

Device Problems Kinked (1339); Defective Component (2292); No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2016

Event Type  malfunction  

Event Description

The pain management physician was doing a caudal epidural steroid injection with an epidural catheter.The catheter connector was defective as the physician could not push medication through the connector.The connector also kinked up the catheter.The catheter was ok to use but we needed to open a new package of catheter with connector in order to finish the procedure.The patient tolerated the procedure well and there were no complications.

• Brand Name: BREVI STF
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): EPIMED INTERNATIONAL, INC.; 13958 diplomat drive; farmers branch TX 75234
• MDR Report Key: 6102203
• MDR Text Key: 59941600
• Report Number: 6102203
• Device Sequence Number: 1
• Product Code: BSO
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: 155-2343
• Device Lot Number: 11436505
• Other Device ID Number: 19 GAUGE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2016
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/17/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 70