MAUDE Adverse Event Report: BD ALARIS PUMP INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2420-0007

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2021

Event Type  malfunction  

Event Description

During the infusion, fluids began leaking and, after examination, a small slit was noted in the tubing about 1 1/2 inches below the last port.Fda safety report id# (b)(4).

• Brand Name: ALARIS PUMP INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD
• MDR Report Key: 12452811
• MDR Text Key: 271068305
• Report Number: MW5103830
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: 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 Age: 2 DA