MAUDE Adverse Event Report: ICU MEDICAL, INC MEDEX STOPCOCKS; STOPCOCK, I.V. SET

Catalog Number	MX5311L
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.The event happened on various days.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 information becomes available.The device has not been returned to the manufacturer.
Event or Problem Description
It was reported that the client was seen twice a week between (b)(6) 2025 that the 3 way stop cock leaking on multiple occasions, the reporter at first thought it was not connected appropriately.The reporter received multiple calls from patient that dressing is leaking, no output in drainage bags.The leak always came from 3 way stop cock connections.Visits done and equipment all well placed, but still leaking, requiring multiple dressing changes to nephrostomy sites.There were 8-10 units involved in multiple incidents.There was a risk of infections.
Additional Manufacturer Narrative
G1: mfg contact info updated.H3: the device was received for evaluation.The device history review of the reported lot number found no non-conformities during the manufacturing process.Visual and functional tests were performed.The customer's stated problem was not confirmed.There was no leakage or device defect found.There was no known cause of the reported issue, and no further action will be taken.

• Brand Name: MEDEX STOPCOCKS
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 22557875
• Report Number: 1526863-2025-00081
• Device Sequence Number: 9528653
• Product Code: FMG
• UDI-Device Identifier: 10351688506795
• UDI-Public: (01)10351688506795(17)260716(10)4415316
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 07/16/2026
• Device Catalogue Number: MX5311L
• Device Lot Number: 4415316
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown