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

Model Number	MX4341L
Medical Device Problem Codes	Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Other text: device evaluation: no product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.An investigation into the part and lot number found that there were no relation of reported problem during the manufacturing of this part.A 2-year review of the complaint database found no similar complaints.Without the parts or pictures of the parts the investigation cannot go any further.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: MEDEX STOPCOCK
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16487995
• Report Number: 3012307300-2023-02049
• Device Sequence Number: 20283158
• Product Code: FMG
• UDI-Device Identifier: 10351688507648
• UDI-Public: 10351688507648
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: 08/25/2025
• Device Model Number: MX4341L
• Device Catalogue Number: MX4341L
• Device Lot Number: 4324271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown