MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7.5" (19 CM) APPX 0.56 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4 CL; STOPCOCK, I.V. SET

Catalog Number	MC330358
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The complaint involved a 7.5" (19 cm) appx 0.56 ml, smallbore trifuse ext set w/3 microclave® clear, 4 clamps (1 red, 2 white, 1 blue), luer lock.It was reported that, the inner spongy spring did not come back up that was on the white lumen part.It stayed stuck at the bottom which caused a downstream occlusion.There was patient involvement.There was no patient injured as a result of this incident.
Additional Manufacturer Narrative
One used device was received for evaluation.As received, a stickdown and raised seal were observed on two separate microclaves.No mating device was returned for evaluation.The claves were dissembled, and a broken spike and bent spike were observed, no additional damage or anomalies were confirmed.Complaint of stickdown causing downstream occlusion can be confirmed.The probable cause is due to an incompatible mating device.The directions for use states to avoid damage to the clave or syringes users should confirm mating luers or syringes have an internal diameter range of 0.062¿ to 0.110¿.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 7.5" (19 CM) APPX 0.56 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4 CL
• 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: 22299570
• Report Number: 9617594-2025-01306
• Device Sequence Number: 18460316
• Product Code: FMG
• UDI-Device Identifier: 00887709085275
• UDI-Public: (01)00887709085275(17)300201(10)14295741
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 07/28/2025

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: MC330358
• Device Lot Number: 14295741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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 MATING DEVICE, MFR UNK.; UNSPECIFIED TUBING, MFR UNK.
• Patient Sex: Unknown