MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX; EPIDURAL CATHETER ADAPTER

Device Problem Disconnection (1171)

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

Event Date 01/16/2015

Event Type  No Answer Provided  

Event Description

The patient's adapter to the epidural catheter was found open in bed.The catheter was not connected to the infusion system.The item was discarded and replaced.An international normalized ratio (inr) was drawn and pain control analgesia was initiated.

• Brand Name: PERIFIX
• Type of Device: EPIDURAL CATHETER ADAPTER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon boulevard; allentown PA 18109
• MDR Report Key: 4598904
• MDR Text Key: 5627954
• Report Number: 4598904
• 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: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2015
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 69