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

Catalog Number	MX5341L
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the staff were called to the patient¿s room when the writer found blood backing up in the line and leaking onto the sheets.The writer paused the heparin and tacrolimus infusions and discovered that the extension piece had come loose at the stopcock.The registered nurse tightened the connection and notified the charge nurse, who decided that the micro-extension piece and stopcock should be replaced, while the rest of the line could be kept.Blood return at the cap was observed and wasted, the line was flushed, and the new tubing was connected.The line infused without any issues for the rest of the night.The person affected was an inpatient, including those under observation.No harm reached the patient, and no monitoring was required.The medication involved was tacrolimus running at 1.23 ml per hour, and it was ordered, dispensed, and administered as prescribe.
Additional Manufacturer Narrative
H3: 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
Based on the investigation, the leak was traced to a third-party extension set not manufactured by icu medical, rather than the icu medical product itself.Therefore, the issue is not attributed to icu medical¿s manufacturing processes.It is recommended that the defect be reported to the manufacturer of the extension set for a complete investigation.

• Brand Name: SMALL BORE 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 ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24562692
• Report Number: 3012307300-2026-02228
• Device Sequence Number: 21215190
• Product Code: FMG
• UDI-Device Identifier: 10351688506788
• UDI-Public: (01)10351688506788
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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 Catalogue Number: MX5341L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown