MAUDE Adverse Event Report: BD IV INFUSION TUBING SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2420-007

Device Problems Obstruction of Flow (2423); Priming Problem (4040)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2023

Event Type  malfunction  

Event Description

An rn(registered nurse) was priming bd alaris pump infusion set with iv fluid and noticed that a section of the tubing began bulging.This section of tubing is the section that is placed within the alaris pump channel.The rn removed this tubing and obtained a new bag of iv fluid and tubing.Bd alaris lvp 20d 2ss cv.

• Brand Name: IV INFUSION TUBING SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD; MX
• MDR Report Key: 17020171
• MDR Text Key: 316229346
• Report Number: MW5117965
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-007
• Device Catalogue Number: 07613203021012
• Device Lot Number: (10)23015615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PUMP