MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5.5" (14 CM) APPX 1.2 ML, SMALLBORE QUADFUSE EXT SET W/3 CLAVE¿, 3 CHECK VALVES,; STOPCOCK, I.V. SET

Catalog Number	B33982
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although multiple attempts were made to obtain the device, it has not been yet received.A review of the device history record is pending.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a 5.5" (14 cm) appx 1.2 ml, smallbore quadfuse ext set w/3 clave¿, 3 check valves, 4 clamps (red, white, green, yellow), luer lock that reportedly leaked an unspecified fluid/infusate.The facility will no longer use this device because of the leakage issue.The total affected product amount was 3 cases and they have requested credit.There was no report of any human harm.
Additional Manufacturer Narrative
Investigation summary: the reported complaint of a leak could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed, and a probable cause cannot be determined.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.Additional information d9 section.
Additional Manufacturer Narrative
Five 5.5" (14 cm) appx 1.2 ml, smallbore quadfuse ext set w/3 clave¿, 3 check valves, 4 clamps (red, white, green, yellow), luer lock were returned for evaluation on 10/29/2025.No visual damages or anomalies were observed.The samples were tested and primed at gravity pressure from each port with no issues.The samples were pressure leak tested at 25psi at each port with no leaks observed.The reported complaint of a leak could not be confirmed from the returned samples.The returned samples were tested and met product specifications.Without the return of the actual used sample, a probable cause cannot be determined.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 5.5" (14 CM) APPX 1.2 ML, SMALLBORE QUADFUSE EXT SET W/3 CLAVE¿, 3 CHECK VALVES,
• 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: 22322249
• Report Number: 9617594-2025-01327
• Device Sequence Number: 12998770
• Product Code: FMG
• UDI-Device Identifier: 00887709127159
• UDI-Public: (01)00887709127159(17)290701(10)14086194
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2026

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: B33982
• Device Lot Number: 14086194
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 12/09/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/24/2025; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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: UNSPECIFIED FLUID/INFUSATE, MFR UNK.
• Patient Sex: Unknown