MAUDE Adverse Event Report: BD / CAREFUSION 303, INC. BD ALARIS PUMP INFUSION SET 0.2 MICRON FILTER; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10010454

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2022

Event Type  malfunction  

Event Description

The iv tubing kept sucking air into the filter as the nurse was priming the tubing.This has occurred in the past and has been reported to the fda.Fda safety report id # (b)(4).

• Brand Name: BD ALARIS PUMP INFUSION SET 0.2 MICRON FILTER
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD / CAREFUSION 303, INC.
• MDR Report Key: 13251626
• MDR Text Key: 283846027
• Report Number: MW5106626
• 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: 01/10/2022

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: 01/05/2024
• Device Model Number: 10010454
• Device Catalogue Number: 10010454
• Device Lot Number: (10)21015209
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American