MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V. Medex Transtar Pressure Transducer; probe, blood-flow, extravascular

Catalog Number	MX9505T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood was drawn via the right radial artery catheter.During flushing, leakage was observed at the sealed connection between the saline line and sensor.The consumable was replaced.There was a patient involvement and there were no additional adverse consequences.
Additional Manufacturer Narrative
The suspected device was not returned for evaluation.Therefore, visual inspection and functional testing could not be performed.The device history review was performed, and no nonconformities were identified that may have contributed to the reported complaint.The customer reported leakage could not be confirmed.Based on the information provided and the absence of the device for evaluation, a probable cause could not be determined.

• Brand Name: Medex Transtar Pressure Transducer
• Common Device Name: probe, blood-flow, extravascular
• 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 ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50818553
• Report Number: 9616567-2026-00031
• Device Sequence Number: 21370403
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: (01)10351688503992(17)280619(10)6117641
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: CH
• PMA/510(K) Number: K942377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: MX9505T
• Device Lot Number: 6117641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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