MAUDE Adverse Event Report: B. BRAUN ADDEASE CONNECTORS

Model Number BC2000

Device Problems Improper or Incorrect Procedure or Method (2017); Defective Component (2292); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 03/02/2017

Event Type  malfunction  

Event Description

There have been many events involving the addease connectors.Some of which are user error (these are not user friendly).Others involve the device having too much adhesive or other defects.They have been sent back to the mfr on multiple occasions and defects are noted.(b)(6) us.

• Brand Name: ADDEASE CONNECTORS
• Type of Device: ADDEASE CONNECTORS
• Manufacturer (Section D): B. BRAUN
• MDR Report Key: 6380682
• MDR Text Key: 69255665
• Report Number: MW5068277
• Device Sequence Number: 1
• Product Code: LHI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other