MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V Medex Hi-Flo 3 Gang, 4-Way Manifold w/MLL; Stopcock, i.V. Set

Catalog Number	MX4345LM
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that during therapy, the manifold was cracked and begin to leak.This issue which resulted in critically ill and unstable decompensating, also bp drastically dropping and nearly coding for the patient, including possible exposure to the drug.The manifold was replaced and epinephrine was administered to stabilize the patient.There was patient involvement and harm was reported.

• Brand Name: Medex Hi-Flo 3 Gang, 4-Way Manifold w/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; parque industrial monterrey; apodaca nuevo leon NA 66603 ; MX 66603
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 60045 ; +1(224)706-2300
• MDR Report Key: 50101319
• Report Number: 1526863-2026-00160
• Device Sequence Number: 18652003
• Product Code: FMG
• UDI-Device Identifier: 10351688507594
• UDI-Public: (01)10351688507594
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: MX4345LM
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown