MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE TRIFUSE EXT SET W/REMV 3 MICROCLAVE® CLEAR (GLOW, PURPLE RINGS); STOPCOCK, I.V. SET

Catalog Number	MC33917
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a leak could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.No lot received for a history review.
Event or Problem Description
The event occurred on an unspecified date involving a 7" smallbore trifuse ext set w/remv 3 microclave® clear (glow, purple rings), 3 clamps, rotating luer where it was reported that the hospital was still experiencing issues with leaking from the microclave.The reporter identified that the bd 10011865 0.2-micron filter set was an incompatible mating device and there may be additional factors contributing to the leaking.There was unknown patient involvement and unknown adverse events.

• Brand Name: 7" SMALLBORE TRIFUSE EXT SET W/REMV 3 MICROCLAVE® CLEAR (GLOW, PURPLE RINGS)
• 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: 21085718
• Report Number: 9617594-2025-00028
• Device Sequence Number: 17850427
• Product Code: FMG
• UDI-Device Identifier: 00887709071605
• UDI-Public: 00887709071605
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/06/2025

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: MC33917
• 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: 12/09/2024
• Initial Report FDA Received Date: 01/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 10011865 0.2-MICRON FILTER SET, BD.
• Patient Sex: Unknown