MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. 7" (18 cm) Appx 0.62 ml, Smallbore Quadfuse Ext Set w/4 MicroClave® Clear, 4 Cla; stopcock, i.v. set

Catalog Number	MC330479
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 7" (18 cm) appx 0.62 ml, smallbore quadfuse ext set with 4 microclave clear, 4 clamps, luer lock reported that when the staff from customer facility was preparing and flushing quadfuse for use, one line was unable to flush.Upon removing the syringe, it was found that the clave was broken and did not recoil back into position.Upon opening package, no defect was observed.Registered nurse began priming the 4 lines with saline and noticed the clave was broken when removing the flush from that specific clave prior to patient use.The quadfuse was not used on a patient.Only saline had been flushed through the quadfuse and was not used on a patient.There was no patient involvement and no patient harm.
Additional Manufacturer Narrative
The device is available for evaluation; however, has not been received.

• Brand Name: 7" (18 cm) Appx 0.62 ml, Smallbore Quadfuse Ext Set w/4 MicroClave® Clear, 4 Cla
• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50871523
• Report Number: 9617594-2026-01325
• Device Sequence Number: 10690647
• Product Code: FMG
• UDI-Device Identifier: 00887709090200
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: MC330479
• Device Lot Number: 14624417
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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
• Patient Sex: Unknown