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

Model Number	1194802
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The clear flexible tubing that goes into the spike slid out of the spike causing tpn to spill.When i place the flexible tubing back into the bottom of the spike, it pulls out very easily.The device was retained however packing as disposed of.This did not negatively impact the patient.

• Brand Name: PLUM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC.; highway 301 north; rocky mount NC 27801
• MDR Report Key: 7442745
• Report Number: 7442745
• Device Sequence Number: 16683613
• Product Code: FPA
• UDI-Device Identifier: 10887787005179
• UDI-Public: (01)10887787005179
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2018
• Report Date (Section F): 04/10/2018

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
• Operator of Device: No Information
• Device Model Number: 1194802
• Device Catalogue Number: 1194802
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2018
• 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: 04/10/2018