MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.39 ML, SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, 0.2 MICRON FILTE; STOPCOCK, I.V. SET

Catalog Number	MC33933
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a smallbore extension set w/ microclave and it was reported that filter section of tubing to be sticky on exterior of flut section of filer.The section was removed while discontinuing total parenteral nutrition (tpn).There was patient involvement, but no patient harm/ adverse event reported.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.Additional contact information: (b)(6).
Additional Manufacturer Narrative
D9 - date returned to mfg: 12/8/2025.Received one (1) used mc330533 smallbore ext set for inspection.The filter was wetted out with prior infusate.The set was leak tested per product specifications.There was leakage from the filter vents.The reported complaint of leakage can be confirmed.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.

• Brand Name: 7" (18 CM) APPX 0.39 ML, SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, 0.2 MICRON FILTE
• 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: 23601347
• Report Number: 9617594-2025-02191
• Device Sequence Number: 21144613
• Product Code: FMG
• UDI-Device Identifier: 00887709072510
• UDI-Public: (01)00887709072510(17)300701(10)14504927
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: MC33933
• Device Lot Number: 14504927
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/27/2026
• 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: TOTAL PARENTERAL NUTRITION, UNK MFR.
• Patient Sex: Unknown