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

Model Number MS3500-15

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 07/02/2021

Event Type  malfunction  

Event Description

Spike was dirty in closed packaging.Went to spike a bag and found a dark brown/red particle.

• Brand Name: ALARIS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 12287028
• MDR Text Key: 265406303
• Report Number: 12287028
• 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
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS3500-15
• Device Catalogue Number: MS3500-15
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1