MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8.5" (22 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR; STOPCOCK, I.V. SET

Catalog Number	MC33795
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation; however, a photo review needs to be performed, and a supplemental report will be submitted.A device history review could not be completed due to the unknown lot number.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved an 8.5 inch (22 cm) appx 0.68 ml, smallbore trifuse ext set with 3 microclave clear (1 remv), 3 clamps, rotating luer, and it was reported that the device was disconnected.The tubing was disconnected from the trifuse that was attached to the cap of the picc (peripherally inserted central catheter) line.The picc line was clamped and removed the end of the trifuse that remained.Total parenteral nutrition (tpn) was paused on the pump.There were a patient involvement and no patient harm.

• Brand Name: 8.5" (22 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR
• 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: 25455176
• Report Number: 9617594-2026-00561
• Device Sequence Number: 16054911
• Product Code: FMG
• UDI-Device Identifier: 00887709068049
• UDI-Public: (01)00887709068049
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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: MC33795
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 06/24/2026
• 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; PICC LINE, UNK MFR; TOTAL PARENTERAL NUTRITION, UNK MFR
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Weight: 7 KG