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	Material Separation (1562)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An event involving smallbore quadfuse ext set w/4 microclave clear clamps reported that the bifuse were breaking off at the connection site to the patient occurred in patient use with medication continuous infusions.There was patient involvement, there was delay in sedation and line was occluded and no harm/adverse event reported.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
D9 - date returned to mfr: 2/26/2026.Received one (1) used mc330479 smallbore quadfuse ext set and one (1) used non-icu medical needleless acces device for inspection.The non-icu medical mating device had the tip broken off in the male luer of the quadfuse set.The reported complaint could not be confirmed.The break was on a non-icu medical device.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24468473
• Report Number: 9617594-2026-00206
• Device Sequence Number: 10308408
• Product Code: FMG
• UDI-Device Identifier: 00887709090200
• UDI-Public: (01)00887709090200(17)301101(10)14792935
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 14792935
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/25/2025
• 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