MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERFIX; LOCAL ANAESTHESIA CONDUCTION CATHETER

Catalog Number 555296

Device Problems Material Separation (1562); Torn Material (3024)

Patient Problem Pain (1994)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

Epidural catheter found to be separated and shredded between patient and filter.Anestheia notified, attempted to cut clean edge with sterile scissors, but unable to make adequate connection with filter.Epidural catheter was replaced and the impact to the patient was interruption in pain management.

• Brand Name: PERFIX
• Type of Device: LOCAL ANAESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; 901 marcon boulevard; allentown PA 18109
• MDR Report Key: 3708357
• MDR Text Key: 4330984
• Report Number: 3708357
• Device Sequence Number: 1
• Product Code: BSO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 555296
• Device Lot Number: 61339395
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PUMP
• Patient Age: 29 YR