MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MONITORING KIT W/TRANSPAC® IV, 30 ML SQUEEZE FLUSH DEVICE, 10 CC CONTAMINATION S; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46114-98
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a monitoring kit w/transpac® iv, 30 ml squeeze flush device, 10 cc contamination syringe and blood sampling port that experienced leakage.The report stated that nicu is reporting issues with leaking at certain parts of item.There was unknown patient.
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 1jul2025 has been used as a placeholder.Investigation summary: the complaint could not be confirmed.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: MONITORING KIT W/TRANSPAC® IV, 30 ML SQUEEZE FLUSH DEVICE, 10 CC CONTAMINATION S
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22790008
• Report Number: 9617594-2025-01666
• Device Sequence Number: 21287873
• Product Code: DRS
• UDI-Device Identifier: 00887709082113
• UDI-Public: (01)00887709082113(17)270901(10)14145147
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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: 46114-98
• Device Lot Number: 14145147
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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