MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MX493
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient came to the clinic for 5fu infusion pump disconnect.Rn noticed white residue on black pouch and completed infusion bag.Tubing connecter between bag and tubing was loose.Adapter (medex double male luer lock (mx493)) between the medication bag and the cadd pump tubing.It is believed the leaking was occurring at the adapter site.

• Brand Name: MEDEX
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 14436160
• Report Number: 14436160
• Device Sequence Number: 5124459
• Product Code: FPA
• UDI-Device Identifier: 10351688506917
• UDI-Public: (01)10351688506917
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/06/2022
• Report Date (Section F): 05/06/2022

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
• Device Model Number: MX493
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/19/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 05/06/2022