MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	460990471
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and (b)(6) 2025 has been used as a placeholder.D4 and h4 the lot#, expiration date, and manufacture date are unknown.Investigation summary: 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.
Event or Problem Description
A medwatch was received regarding a monitoring kit w/safeset¿ ii, 03 ml flush device & marvelous valve that experienced leakage during use.It was reported that "patient had r [right] ulnar a-line [arterial line].Tubing not due until tomorrow night.Grabbing blood to send down a lactic acid.Blood drawn.As pushing through "wasted" blood through safeset, balloon in syringe pops.Blood leaks quickly out of syringe from a-line.Line clamped.Tubing changed." additional event information obtained from ufmw: this is not a laboratory device or laboratory test.The location where event occurred was in hospital¿s critical care.

• Brand Name: MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE
• 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: 22812661
• Report Number: 9617594-2025-01689
• Device Sequence Number: 20999221
• Product Code: DRS
• UDI-Device Identifier: 00840619069087
• UDI-Public: 00840619069087
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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: 460990471
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/14/2025
• 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