MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33131
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of leaks on item mc33131 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.
Event or Problem Description
It was reported on an unknown date that a 7" (18 cm) appx 0.43 ml, pressure infusion (400psig) ext set w/microclave¿ clear, purple clamp, rotating luer generated a leak during patient use.It was reported that they are experiencing leaking radioactive isotopes at the end of the nuclear medicine infusion.This also happened even if they have a dual-cap disinfection cap on the end of the clave.The leaking occurred after they unhooked anything from the line, the syringe containing blood, after injecting isotopes, after injecting saline, etc.There was patient involvement and no human harm.

• Brand Name: 7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22628238
• Report Number: 9617594-2025-01538
• Device Sequence Number: 20830468
• Product Code: FPA
• UDI-Device Identifier: 00887709037434
• UDI-Public: 00887709037434
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• 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
• Type of Report: Initial
• Report Date (Section B): 07/27/2025

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: MC33131
• Device Lot Number: NOT PROVIDED
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/28/2025
• 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