MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, RO; STOPCOCK, I.V. SET

Catalog Number	B33098
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 4" (10 cm) appx 0.40 ml, smallbore trifuse ext set w/3 microclave®, 3 clamps, rotating luer.One trifuse of the device was squirting saline during a flush.As additional information, when changing dressing pack for the patient, they also noticed blood backing into the tubing during the flush.There was no report of any human harm.
Additional Manufacturer Narrative
A photo was received from the customer showing the affected sample.No conclusions could be made from the photo.The reported complaint of backflow could not be confirmed.Without the return of the used sample a comprehensive review cannot be performed and a probable cause cannot be determined.No lot received for a device history record review.

• Brand Name: 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, RO
• 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: 22019042
• Report Number: 9617594-2025-00991
• Device Sequence Number: 8733815
• Product Code: FMG
• UDI-Device Identifier: 00887709006263
• UDI-Public: 00887709006263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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: B33098
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/14/2025
• 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: SALINE SOLUTION, MFR UNK.; UNSPECIFIED DRESSING PACK, MFR UNK.
• Patient Sex: Unknown