MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 1.4 ML, PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, 1.2; STOPCOCK, I.V. SET

Catalog Number	MC330472
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a 60" (152 cm) appx 1.4 ml, pur yellow smallbore ext set w/microclave¿ clear, 1.2 micron filter, clamp, luer lock.The reporter stated that they had a leaking filter (unspecified infusate).There was no human harm associated with this complaint/event.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.E1: initial reporter full phone: (b)(6).
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.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 a cause cannot be determined.

• Brand Name: 60" (152 CM) APPX 1.4 ML, PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, 1.2
• Common Device Name: STOPCOCK, I.V. SET
• 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: 20400296
• Report Number: 9617594-2024-01395
• Device Sequence Number: 15082445
• Product Code: FMG
• UDI-Device Identifier: 00887709095854
• UDI-Public: (01)00887709095854(17)280601(10)13684054
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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,Followup
• Report Date (Section B): 03/11/2025

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: MC330472
• Device Lot Number: 13684054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2023
• 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: UNSPECIFIED INFUSATE, MFR UNK.
• Patient Sex: Unknown