MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX STOPCOCK 3 WAY TUBING 20 IN; STOPCOCK, I.V, SET

Model Number	MX412SL
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Iv contrast was leaking at the cockstop port, patient did not consume all of contrast for testing.

• Brand Name: MEDEX STOPCOCK 3 WAY TUBING 20 IN
• Common Device Name: STOPCOCK, I.V, SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC. ; dublin OH 43016
• MDR Report Key: 8208386
• Report Number: MW5082714
• Device Sequence Number: 202678
• Product Code: FMG
• UDI-Device Identifier: 10351688507860
• UDI-Public: (01)10351688507860(17)21008(10)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/28/2018

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: Health Professional
• Device Expiration Date: 10/08/2021
• Device Model Number: MX412SL
• Device Lot Number: 3700133
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1