MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V MEDEX HIGH PRESSURE MANIFOLDS; STOPCOCK, I.V. SET

Catalog Number	MX4343LM
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had a spontaneous drop in blood pressure after the staff moved the head of bed up to 45 degrees.The blood pressure dropped as low as 60/30 despite increased titration of vasopressors and then recovered with fluid bolus and phenylephrine bolus.It was noted after about 15-20 minutes that the pressor infusions were not going into patient's cvc because the manifold had come unscrewed from the port.This was quickly cleaned and reattached and patient's blood pressure recovered.End of manifold that screws on to port of infusion catheter sometimes becomes loose and can come apart.There have been a few instances of this happening with this device on the unit.There was no patient harm/adverse event.
Additional Manufacturer Narrative
H3: no product was received for analysis.We are unable to confirm the reported complaint.Without the return of the samples used a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record could not be completed as no lot number was received.
Additional Manufacturer Narrative
H6: codes were updated.No device was received for investigation.Therefore, the reported complaint is unable to be confirmed.If the device is received, the investigation will be re-opened for further evaluations.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: MEDEX HIGH PRESSURE MANIFOLDS
• 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: 24203031
• Report Number: 1526863-2026-00010
• Device Sequence Number: 14823725
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: MX4343LM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/02/2026
• 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
• Patient Sex: Unknown