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

Model Number MX4341L

Device Problems Obstruction of Flow (2423); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2023

Event Type  malfunction  

Event Description

It was reported that the device is unable to run iv fluids to gravity with stopcock in-situ.Limits iv flow.Also lots of resistance when flushing via side port.There has been no report of patient involvement, no observable clinical symptoms, or a change in symptoms identified in the patient.

Manufacturer Narrative

Protocol number is blank as device is exempt.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: MEDEX STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16473338
• MDR Text Key: 310590481
• Report Number: 3012307300-2023-01957
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688507648
• UDI-Public: 10351688507648
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX4341L
• Device Catalogue Number: MX4341L
• Device Lot Number: 4324271
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1