MAUDE Adverse Event Report: ICU MEDICAL 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	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three pictures were received from customer for further analysis.The images send by customer were visually inspected by unaided eye and it was possible to see the product leaking reported in this complaint.The device history record of reported lot 6058637 was reviewed and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Without the return of a physical sample of this complaint, a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.An internal investigation is being performed to investigate leakage failures associated with finished good mx9505t, which has been identified as the primary affected product.The leakage was localized at the union between tubing p/n 125-c and the female luer lock p/n 550-007.
Event or Problem Description
It was reported that the anesthesiology department connected the device for use and the doctor noticed blood leakage at the joint.There was patient involvement.No patient harm/adverse event was reported.

• Brand Name: MEDEX TRANSTAR PRESSURE TRANSDUCER
• Common Device Name: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL 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: 24345269
• Report Number: 1526863-2026-00018
• Device Sequence Number: 10041020
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: (01)10351688503992(17)271125(10)6058637
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: 6058637
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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