MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SINGLE LINE ARTERIAL KIT W/03 ML PTSF AND TP4; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46101-56
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: the date of event is unknown, and 01 sep 2025 has been used as a placeholder.The device is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
Event occurred regarding a single line arterial kit w/03 ml ptsf and tp4 where it was reported that the nurse was drawing labs from the arterial catheter, the nurse turned the arterial line off to the flush bag and attached syringe with blunt tip to the upper sampling port.The nurse began to aspirate the waste and noticed the sample appeared foamy.As the nurse withdrew the syringe from the sampling port, blood was visible on the port.The nurse proceeded to obtain the specimen by attaching a 10 ml syringe with blunt tip to the lower sampling port.As the nurse aspirated, the sample was foamy and mixture of blood and air.When the syringe was withdrawn, blood leaked from the port.The nurse confirmed there was no air visible in the high-pressure tubing, the high-pressure bag was inflated to 300 mm hg millimeters of mercury, all access ports had solid caps, and connections all tightened.The common device name is transducer, blood pressure, extravascular.There was patient involvement.

• Brand Name: SINGLE LINE ARTERIAL KIT W/03 ML PTSF AND TP4
• 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: 23646226
• Report Number: 9617594-2025-02217
• Device Sequence Number: 9961748
• Product Code: DRS
• UDI-Device Identifier: 00887709050617
• UDI-Public: (01)00887709050617(17)280501(10)14419109
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: 46101-56
• Device Lot Number: 14419109
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2025
• 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: Male
• Patient Race: White