MAUDE Adverse Event Report: BECTON DICKSON BECTON DICKSON SET INFUSION CHECK VALVE; INTRAVASCULAR ADMINISTRAVIE SET

Device Problems Disconnection (1171); Split (2537); Material Protrusion/Extrusion (2979)

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

Event Date 08/20/2017

Event Type  malfunction  

Event Description

Alaris iv pump tubing became completely disconnected at area of insertion into the pump surrounding the blue plastic fitting.The area that became disconnected (split into half) was the very soft pliable area of the tubing that is inserted into the pump itself where the chamber assesses for air bubbles.Second tubing set issue was a large bubble that protruded out of the same area discussed above in the soft pliable area in the tubing.Diagnosis or reason for use: iv pump tubing dehp free, iv tubing administration set.

• Brand Name: BECTON DICKSON SET INFUSION CHECK VALVE
• Type of Device: INTRAVASCULAR ADMINISTRAVIE SET
• Manufacturer (Section D): BECTON DICKSON
• MDR Report Key: 6843470
• MDR Text Key: 84992107
• Report Number: MW5071961
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 08/24/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2017
• 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 Age: 3 MO