MAUDE Adverse Event Report: BRAUN DISCOFIX; MANIFOLD

Model Number 513552

Device Problem Difficult to Flush (1251)

Patient Problem No Information (3190)

Event Date 07/07/2014

Event Type  malfunction  

Event Description

Unable to flush manifold.Date of use: (b)(6) 2014.Diagnosis or reason for use: multiple iv medications.Event abated after use stopped: yes.

• Brand Name: DISCOFIX
• Type of Device: MANIFOLD
• Manufacturer (Section D): BRAUN; bethleham 18018
• MDR Report Key: 3963543
• MDR Text Key: 4555865
• Report Number: MW5037459
• Device Sequence Number: 2
• Product Code: DTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/24/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 513552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 80