MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAM; STOPCOCK, I.V. SET

Catalog Number	MC330027
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.
Event or Problem Description
The complaint/event involved occurred on an unspecified date in april 2025 and involved a 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w/3 microclave® clear, 3 clamps, luer lock.The reporter stated that in the last week, they had an uptick of incidents in relation to the use of the trifuse device from icu medical.For this specific event, the nurse was called into the room due to carboplatin chemo tubing disconnecting.Chemo pieces were disconnected from the trifuse.A minimal amount of chemo was lost.It was stated that the patient's mom transferred the patient from holding him in the chair to the crib and the tpn line got disconnected at the site where it connects to the t connector.This rn noticed line was laying on the floor- placed a blue cap on the line and notified the team.Cat team nurse was also in the room for a dressing change with the rn.The med team ordered the tpn to hang earlier to minimize the time off of tpn and to keep patient on home schedule.This rn disposed of the tpn bag and tubing that fell onto the floor.The location was w12.The product could potentially have come in contact with the patient and/or staff member, yet the medication that was being administered, did not get on patient or staff skin or clothing.The chemo spill was cleaned up per facility protocol.There was no staff or patient harm reported as a result of the event.

• Brand Name: 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAM
• 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: 22064113
• Report Number: 9617594-2025-01077
• Device Sequence Number: 7633984
• Product Code: FMG
• UDI-Device Identifier: 00887709076419
• UDI-Public: 00887709076419
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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: MC330027
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/21/2025
• 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: CARBOPLATIN, MFR UNK.; INFUSION BAG OF TPN, MFR UNK.; TPN LINE/TUBING, MFR UNK.; UNSPECIFIED BLUE CAP, MFR UNK.
• Patient Sex: Unknown