MAUDE Adverse Event Report: BD SWITZERLAND SÀRL ALARIS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2260-0500
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Ivig tubing very hard to prime.Have had this happen multiple times.

• Brand Name: ALARIS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD SWITZERLAND SÀRL; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 20189312
• Report Number: 20189312
• Device Sequence Number: 7003211
• Product Code: FPA
• UDI-Device Identifier: 07613203012591
• UDI-Public: (01)07613203012591
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/10/2024
• Report Date (Section F): 04/10/2024

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 Model Number: 2260-0500
• Device Catalogue Number: 2260-0500
• Device Lot Number: (10)23126253
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/10/2024