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

Model Number 2426-0007

Device Problems Break (1069); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2023

Event Type  malfunction  

Event Description

The nurse opened a new bd alaris pump infusion set and as she removed it from the package she noticed that the set was in two pieces.She informed her manager and when he inquired about the packaging for device identification, she stated it has been thrown away and the the trash had been removed from the unit.Education provided to retain packaging for any potentially reportable products.

• Brand Name: ALARIS, SMARTSITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 16609422
• MDR Text Key: 311940415
• Report Number: 16609422
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1