MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS SECONDARY BLOOD SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10014081

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 05/06/2022

Event Type  malfunction  

Event Description

The nurse was about to hang a blood product with secondary blood tubing.She removed the blood tubing from the package and noticed the filter was manufactured "upside down".

• Brand Name: ALARIS SECONDARY BLOOD SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92130
• MDR Report Key: 14487050
• MDR Text Key: 292481721
• Report Number: 14487050
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/18/2022

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 Model Number: 10014081
• Device Catalogue Number: 10014081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1