MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.80 ML, SMALLBORE EXT SET W/REMV MICROCLAVE® CLEAR, 0.2 MICRO; STOPCOCK, I.V. SET

Catalog Number	MC33425
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation; however, has not yet been received.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved a smallbore ext set where it was reported that the tubing was wet after running the medication through medfusion line with built in filter.When flushing the medication some of the medication was escaping out of the filter through 2 small holes on the top.Unknown whether the patient received the prescribed dose.There were patient involvement and no harm reported.
Additional Manufacturer Narrative
One used device was received for evaluation; the filter was observed to be wetted out.The reported complaint of a leak could be confirmed.The returned sample was tested and a leak was observed on the inline filter.The filter was observed to have a crack leading to the leak.The probable cause of the crack is unknown.The probable cause of the leak is from the temporary loss of hydrophobic properties during use.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 60" (152 CM) APPX 0.80 ML, SMALLBORE EXT SET W/REMV MICROCLAVE® CLEAR, 0.2 MICRO
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24073650
• Report Number: 9617594-2026-00025
• Device Sequence Number: 13108280
• Product Code: FMG
• UDI-Device Identifier: 00887709038684
• UDI-Public: 00887709038684
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: MC33425
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/06/2026
• 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: UNSPECIFIED MEDICATION, UNK MFR
• Patient Sex: Unknown