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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product had experienced blood backflow.There was no patient harm reported.
Additional Manufacturer Narrative
H3: 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 reportable information becomes available.

• 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; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6250 shier rings road,; dublin, OH 43016 ; 2247062300
• MDR Report Key: 24512702
• Report Number: 1526863-2026-00047
• Device Sequence Number: 10440347
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: (01)10351688503992(17)280428(10)6107176
• 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): 03/04/2026

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: 6107176
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2025
• 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