MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX EPIDURAL ANESTHESIA CATHETER; CATHETER, CONDUCTION, ANESTHETIC

Model Number EC20C

Device Problems Material Separation (1562); Defective Component (2292)

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

Event Date 02/18/2015

Event Type  malfunction  

Event Description

The femoral nerve block tubing is defective and separated.This resulted in the block being discontinued.

• Brand Name: PERIFIX EPIDURAL ANESTHESIA CATHETER
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon boulevard; allentown, PA 18109
• MDR Report Key: 4575523
• MDR Text Key: 5550936
• Report Number: 4575523
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/23/2015

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: Invalid Data
• Device Model Number: EC20C
• Device Catalogue Number: 333540
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 93