MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY / CAREFUSION 303, INC. ALARIS PUMP INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2260-0500

Device Problems Break (1069); Particulates (1451)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2021

Event Type  malfunction  

Event Description

Nurse report of plastic tip of iv set bag spike and tiny particles of plastic iv bag spike floating within the iv bag.Upon discovery, new medication and iv administration set were obtained.Plastic barrel of spike was sheared off at the base of the 4 openings near the tip of the spike.Fda safety report id # (b)(4).

• Brand Name: ALARIS PUMP INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY / CAREFUSION 303, INC.
• MDR Report Key: 12648521
• MDR Text Key: 277624561
• Report Number: MW5104674
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/13/2021

1 Device was Involved in the Event

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
• Device Expiration Date: 05/14/2024
• Device Model Number: 2260-0500
• Device Catalogue Number: 2260-0500
• Device Lot Number: 10-21056018
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2021
• 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