MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. Transpac® IV Monitoring Kit w/03 ml Squeeze Flush Device, Needleless Valve, 10 c; Transducer, Blood-Pressure, Extravascular

Catalog Number	46115-10
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction

• Brand Name: Transpac® IV Monitoring Kit w/03 ml Squeeze Flush Device, Needleless Valve, 10 c
• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50112770
• Report Number: 9617594-2026-00961
• Device Sequence Number: 18696824
• Product Code: DRS
• UDI-Device Identifier: 00887709082496
• UDI-Public: (01)00887709082496(17)290401(10)14921245
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 46115-10
• Device Lot Number: 14921245
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2026
• 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 Age: 14 DA
• Patient Sex: Female
• Patient Weight: 8 LB