MAUDE Adverse Event Report: ICU MEDICAL, INC., DUBLIN OH MEDEX HIGH PRESSURE MANIFOLDS; STOPCOCK, I.V. SET

Catalog Number	MX4343LM
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: 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 the patient's infusion was ongoing for norepinephrine 0.4 mcg/kg/min and vasopressin 0.04 units/min.Patient was receiving bolus of fluids.Lines were checked and the multi-port device/stopcock manifold (3 ports) was leaking at the needleless connection at the central venous access device (cvad) with pressors infusing; and the bed sheet was noted to be significantly wet.Lines were changed, and the patient's blood pressure was responding effectively to pressors.Pressors were stopped due to blood pressure parameters.There was no patient harm/adverse event reported.
Additional Manufacturer Narrative
G1.Mfg office contact: corrected.Received one device.Visual inspection found no damage.The complaint of leakage cannot be replicated or confirmed.The manifold was capped off and leak tested as per specification.No leakage was observed.The unit was to be found within specification during the leak test.Lot number was not provided therefore lot history review cannot be executed.

• Brand Name: MEDEX HIGH PRESSURE MANIFOLDS
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC., DUBLIN OH; carretera miguel aleman km 21.; 7, parque industrial; monterrey apodaca nuevo leon
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 22440551
• Report Number: 1526863-2025-00075
• Device Sequence Number: 4708902
• Product Code: FMG
• UDI-Device Identifier: 10351688507617
• UDI-Public: (01)10351688507617
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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 Catalogue Number: MX4343LM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/15/2025
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOREPINEPHRINE 0.4 MCG/KG/MIN.; VASOPRESSIN 0.04 UNITS/MIN.
• Patient Sex: Unknown