MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; STOPCOCK, I.V. SET

Model Number	MX9342L
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	08/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
While turning the patient, the yellow double stopcock device became disconnected between the two stopcocks.Three vasopressors were infusing at the time and the nurses involved in the turn had to quickly get another connector to continue to infuse vasopressors.The patients blood pressure did drop and vasopressors had to be titrated up.

• Brand Name: MEDEX
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 18491012
• Report Number: 18491012
• Device Sequence Number: 19755558
• Product Code: FMG
• UDI-Device Identifier: 10351688504166
• UDI-Public: (01)10351688504166
• 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): 08/29/2023
• Report Date (Section F): 08/29/2023

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 Model Number: MX9342L
• Device Lot Number: 4376773
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 96 KG
• Date Report Sent to FDA: 08/29/2023