MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3; STOPCOCK, I.V. SET

Catalog Number	MC33688
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 4" smallbore quadfuse ext set w/4 microclave® clear, 3 check valves, 4 clamps (3 white, red), rotating luer where the reporter stated that peripherally inserted central catheter (picc) line noted to be leaking at quad-fuse site at 03:00.Then upon investigation it was noted that there was backing up and leaking of fluids at the quadfuse.The event occurred during in use for patient at pediatric medicine.Thus, there was patient involvement, unknown human harm and unknown delay in therapy reported.
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending.
Additional Manufacturer Narrative
No mc33688 product samples, videos or photographs were returned for investigation.The dhr was not reviewed, no lot number information was provided.The complaint cannot be confirmed, without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Lot history review was not conducted as no lot number information was provided.

• Brand Name: 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3
• 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: 21414627
• Report Number: 9617594-2025-00321
• Device Sequence Number: 12892647
• Product Code: FMG
• UDI-Device Identifier: 00887709064379
• UDI-Public: 00887709064379
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: MC33688
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/27/2025
• 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: PERIPHERALLY INSERTED CENTRAL CATHETER, MFR UNK.
• Patient Sex: Unknown