MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV KIT W/35" PT, 6" PT AND 3 NEEDLELESS VALVES; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46116-86
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is reported to be available; however, it has not yet been returned.
Event or Problem Description
The event occurred on an unspecified date and involved a transpac® iv kit w/35" pt, 6" pt and 3 needleless valves where the customer reports that the device could not be flushed through.The line was assessed at the patient bedside and found to be working properly, but the transducer could not be flushed through.There was patient involvement but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.No product samples, pictures, or videos were received for investigation.Therefore, a comprehensive failure investigation cannot be performed and a cause cannot be determined.A manufacturing record review could not be completed as the lot number was not provided by the customer.

• Brand Name: TRANSPAC® IV KIT W/35" PT, 6" PT AND 3 NEEDLELESS VALVES
• 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: 21964252
• Report Number: 9617594-2025-00914
• Device Sequence Number: 20620910
• Product Code: DRS
• UDI-Device Identifier: 00887709091696
• UDI-Public: 00887709091696
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 06/25/2025

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: 46116-86
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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