MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 2 CHEC; STOPCOCK, I.V. SET

Catalog Number	MC33687
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: received one (1) used.List #mc33687, 4" (10 cm) appx 0.68 ml, smallbore trifuse ext set w/3 microclave® clear, 2 check valve, 3 clamps (2 white, red), rotating luer; lot #unknown.A microclave was observed to be missing on the trifuse.The reported complaint of a missing microclave could be confirmed.The sample was returned and was missing a microclave.A representative bond was pulled and broke within specifications and showed similar stress marks to the failed sample.The probable cause is from an unintentional pulling force during use.A device history review could not be conducted because no lot number(s) was/were identified.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.D4: only di provided as lot number is unknown.Additional contact information: (b)(6).
Event or Problem Description
The event involved a 4" (10 cm) appx 0.68 ml, smallbore trifuse ext set w/3 microclave clear, 2 check valve, 3 clamps (2 white, red), rotating luer.It was reported that new lines and fluids were started at 16:00, when completing hourly (q1h) peripherally inserted central catheter (picc) assessment at 17:00 the trifuse cap was noted to be missing with curos cap.Line appeared to be snapped.There was patient involvement and no harm/adverse event reported.

• Brand Name: 4" (10 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 2 CHEC
• 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: 24038394
• Report Number: 9617594-2026-00018
• Device Sequence Number: 18762499
• Product Code: FMG
• UDI-Device Identifier: 00887709064362
• UDI-Public: 00887709064362
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: MC33687
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/25/2026
• 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: CUROS CAP, UNK MFR; PERIPHERALLY INSERTED CENTRAL CATHETER, UNK MFR; UNSPECIFIED FLUIDS, UNK MFR
• Patient Sex: Unknown