MAUDE Adverse Event Report: HOSPIRA, INC. LIFESHIELD, PRIMARY PLUM SET, CLAVE Y-SITE, SECURE LOCK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1424228
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Rn hung new primary iv tubing, patient called out shortly after hung stating his iv was bleeding.Rn noted iv was intact and working properly.Upon inspection of the tubing there was a small slit in the tubing about 4 inches from where it connects to the saline lock.Blood has backed up to the slit and was leaking out of the tubing.3 package labels found in the med room.One of which is for this tubing per rn.

• Brand Name: LIFESHIELD, PRIMARY PLUM SET, CLAVE Y-SITE, SECURE LOCK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC.; highway 301 north; rocky mount NC 27801
• MDR Report Key: 7964696
• Report Number: 7964696
• Device Sequence Number: 148840
• Product Code: FPA
• UDI-Device Identifier: 10887787006237
• UDI-Public: (01)10887787006237
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 10/02/2018
• Report Date (Section F): 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 1424228
• Device Catalogue Number: 1424228
• Device Lot Number: 906945H OR 886175H
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/02/2018