MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SM5009 20 DROP UNIV SET W/SMARTSITE VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	SM5009
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Multiple devices missing flow control controller.Fda safety report id # (b)(4).

• Brand Name: SM5009 20 DROP UNIV SET W/SMARTSITE VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; dublin OH 43016
• MDR Report Key: 9540487
• Report Number: MW5092001
• Device Sequence Number: 14023996
• Product Code: FPA
• UDI-Device Identifier: 10351688500595
• UDI-Public: 0110351688500595172205201038
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2019

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 Expiration Date: 05/20/2022
• Device Model Number: SM5009
• Device Lot Number: 3821477
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention