MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY ALARIS IV ADMINISTRATION SET

Device Problem Gas/Air Leak (2946)

Patient Problem No Information (3190)

Event Date 08/30/2018

Event Type  Injury  

Event Description

Rn went to check on the pt and noticed the iv pump had small pockets of air through the tubing but it was still infusing.The secondary fluid bag was empty, and the primary bag was half full and still infusing.The pump was turned off and the iv tubing was disconnected from the pt.

• Brand Name: ALARIS IV ADMINISTRATION SET
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; franlin lakes NJ 07417
• MDR Report Key: 7846728
• MDR Text Key: 119403745
• Report Number: MW5079584
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• 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
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 60