MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20 CM) APPX 0.38 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMP; STOPCOCK, I.V. SET

Catalog Number	MC330359
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation: it has not been received.The investigation is pending.
Event or Problem Description
The event involved a 8" (20 cm) appx 0.38 ml, smallbore bifuse ext set w/2 microclave¿ clear, 2 clamps (white, blue), luer lock.It was reported that the patient had medications running through a bifurcate on his double lumen peripherally inserted central catheter (picc).A nurse assessed lines during morning handoff and checked connections.All connections were tight and connected correctly.The patient called out stating that his iv was leaking on him.Nurse returned to the patient's room and found that the bifurcate iv line running tacrolimus was broken.The bifurcate tubing was ripped right below the hub.There was no reported patient harm.
Additional Manufacturer Narrative
The reported complaint of a leak could not be confirmed.Without the return of the sample or photo/video a comprehensive review cannot be performed, and a probable cause cannot be determined.Lot history review was not conducted as no lot number was provided.

• Brand Name: 8" (20 CM) APPX 0.38 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMP
• 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: 23735406
• Report Number: 9617594-2025-02253
• Device Sequence Number: 10631622
• Product Code: FMG
• UDI-Device Identifier: 00887709085282
• UDI-Public: (01)00887709085282
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/05/2026

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: MC330359
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/05/2026
• 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: PERIPHERALLY INSERTED CENTRAL CATHETER, MFR UNK.; TACROLIMUS, MFR UNK.
• Patient Sex: Unknown