MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6.5" (17 CM) APPX 0.63 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CHE; STOPCOCK, I.V. SET

Catalog Number	MC330476
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 6.5" (17 cm) appx 0.63 ml, smallbore bifuse ext set w/2 microclave® clear, 2 check valves, luer lock.The y site was reportedly dripping an unspecified fluid/medication from the luer lock connection in the oncology department.Additional information was later provided by the customer stating the following: while programming a syringe medication, the alaris pump kept alarming "occluded patient side".No kinks were found along the line, and the connections secured.More beeping.Port was aspirated and flushed with good blood return and flushing easily.Syringe pump channel was replaced with no effect.Y site was then replaced and discovered to be 'stuck pushed in".There was no report of any human harm.
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.Section e initial reporter (full) phone: (b)(6).Section e additional contact: lourdes bije quality assurance coordinator the stevens company limited 292236 nose creek blvd rocky view county ab canada t4a 3n7 lourdes.Bije@stevens.Ca 403-640-2858.
Additional Manufacturer Narrative
Two photos were provided by the customer that show the silicone plug stuck down on one of the microclaves on the bifuse set.The reported complaint of leakage on the mc330476 can be confirmed due to the stick down.The probable cause of the stick down is unknown.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.

• Brand Name: 6.5" (17 CM) APPX 0.63 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CHE
• 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: 22037993
• Report Number: 9617594-2025-01026
• Device Sequence Number: 8112632
• Product Code: FMG
• UDI-Device Identifier: 00887709090033
• UDI-Public: 00887709090033
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: MC330476
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: ALARIS PUMP, MFR BD; UNSPECIFIED FLUID/MEDICATION, MFR UNK
• Patient Sex: Unknown