MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V HI-FLO(TM) 2 GANG, 4-WAY MANIFOLD WITH MLL 25/CA; STOPCOCK, I.V. SET

Catalog Number	MX4342LM
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that when the nurse went to draw labs at 0400, 1ml was flushed, then, while drawing back a waste from open push port, only air was being pulled back.Lines were promptly removed and flushed a small amount at lumen hub to ensure lumen was still patent.New line was strung up and hub was changed sterilely.The cap or clave also came off with syringe from the stopcock port.The event occurred while in use with patient.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
D9: device received on 1/9/2026.H3: the device was received for evaluation.The lot number was not provided; therefore, a lot history review could not be performed.Visual and functional tests were performed, which found a leak coming from the female luer.There was also crack in the luer and the clave was unable to draw fluid back.The cause of the crack was unknown, and no further action was taken.

• Brand Name: HI-FLO(TM) 2 GANG, 4-WAY MANIFOLD WITH MLL 25/CA
• 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: 23692496
• Report Number: 1526863-2025-00155
• Device Sequence Number: 9124036
• Product Code: FMG
• UDI-Device Identifier: 10351688507631
• UDI-Public: (01)10351688507631
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 04/15/2026

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 04/15/2026
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown