MAUDE Adverse Event Report: HOSPIRA, INC. LIFESHIELD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1265028
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
T-site noted to be leaking iv fluids.Three devices leaked in total.

• Brand Name: LIFESHIELD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC.; highway 301 north; rocky mount NC 27801
• MDR Report Key: 17237143
• Report Number: 17237143
• Device Sequence Number: 17581112
• Product Code: FPA
• UDI-Device Identifier: 10887787005490
• UDI-Public: (01)10887787005490
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/13/2023
• Report Date (Section F): 06/13/2023

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: 1265028
• Device Catalogue Number: 1265028
• Device Lot Number: 5634770
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2023
• 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: 06/13/2023