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

Catalog Number 2426-0500

Device Problems Connection Problem (2900); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 05/27/2021

Event Type  malfunction  

Event Description

New bd alaris pump infusion set and the tubing was not connected to the chamber below the spike.This break sterility / cleanliness of the product and it needed to be wasted.Infusion center will keep the tubing for a short time if it needs to be collected.

• Brand Name: BD ALARIS PUMP INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD, SWITZERLAND SARL
• MDR Report Key: 12149721
• MDR Text Key: 261227344
• Report Number: MW5102450
• Device Sequence Number: 1
• Product Code: FPA
• 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: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/29/2023
• Device Catalogue Number: 2426-0500
• Device Lot Number: (10)20053476
• 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