MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V HI-FLO(TM) 2 GANG, 4-WAY MANIFOLD WITH MLL; STOPCOCK, I.V. SET

Catalog Number	MX4342LM
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a leakage in between plastic of stopcock.Sedatives infusing, causing propofol to leak.The event occurred while in use with patient.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
G1 - mfg contact office address 1, contact office city, contact office zip code, state, country: corrected.H3/h6: one used device was returned for analysis in used condition.The device was visually inspected.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Functional testing was performed.The reported issue was unable to be duplicated.The cause of the reported issue was not determined as no issue was identified through testing.

• Brand Name: HI-FLO(TM) 2 GANG, 4-WAY MANIFOLD WITH MLL
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 23595031
• Report Number: 1526863-2025-00133
• Device Sequence Number: 21208575
• Product Code: FMG
• UDI-Device Identifier: 10351688507631
• UDI-Public: (01)10351688507631(17)270722(10)6025959
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: MX4342LM
• Device Lot Number: 6025959
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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