MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 84" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MA; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	42801-05
Medical Device Problem Codes	Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for return; however, it has not yet been received.
Event or Problem Description
The complaint involved a transpac¿ it monitoring kit, 84" pressure tubing, 3ml flush device, un-bonded macrodrip device.Upon disconnecting and reconnecting the patient's arterial line/setup to an existing arterial line tubing for line change, the line was reportedly leaking blood from the existing tubing connected to patient arterial line catheter.Also, when attempting to aspirate blood, the device also pulled air into the setup.There were no other devices being used on the patient at the time of the event that may have caused or contributed to the event.The patient involved was a 24.3 years old, male and with unspecified patient harm.
Additional Manufacturer Narrative
One used partial list #42801-05, transpac¿ it monitoring kit, 84" pressure tubing, 3ml flush device, un-bonded macrodrip was returned for evaluation.As received, a crack on the female luer and tooling mark evidences.The returned set was tested and a leaks from the crack was confirmed.This complaint of leaks can be confirmed.The probable of the crack is unknown.However, the damage on the female luer is typical of tooling marks applied during use.A dhr lot # review could not be conducted because no lot number was identified.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 84" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MA
• 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: 22700420
• Report Number: 9617594-2025-01592
• Device Sequence Number: 13021074
• Product Code: DRS
• UDI-Device Identifier: 00887709120679
• UDI-Public: 00887709120679
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• 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): 10/28/2025

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: 42801-05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATERIAL LINE W/CATHETER, MFR UNK.
• Patient Age: 24 YR
• Patient Sex: Male