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

Model Number	1205328
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Rns were attempting to start an iv on a patient.After getting iv site, rns attempted to connect extension set and upon securing device to hub of iv catheter the spin collar device detached from the device.
Event or Problem Description
Rns were attempting to start an iv on a patient.After getting iv site, rns attempted to connect extension set and upon securing device to hub of iv catheter the spin collar device detached from the device.

• Brand Name: LIFESHIELD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC.; highway 301 north; rocky mount NC 27801
• MDR Report Key: 8607418
• Report Number: 8607418
• Device Sequence Number: 11336477
• Product Code: FPA
• UDI-Device Identifier: 10887787005209
• UDI-Public: (01)10887787005209
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019
• Report Date (Section F): 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1205328
• Device Catalogue Number: 1205328
• Device Lot Number: 69194NS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 10
• Date Report Sent to FDA: 05/01/2019