MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6.5" (17 CM) APPX 0.59 ML, SMALLBORE BIFUSE EXT SET, W/CLAVE¿, CHECK VALVE, 2 CL; STOPCOCK, I.V. SET

Catalog Number	B33983
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although multiple attempts were made to obtain the device, it has not been yet received; investigation is pending.A review of the device history record is also pending.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a 6.5" (17 cm) appx 0.59 ml, smallbore bifuse ext set, w/clave¿, check valve, 2 clamps (red, white), 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 2 cases and they have requested credit.There was no report of any human harm.
Additional Manufacturer Narrative
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, and no nonconformities were identified that may have contributed to the reported complaint.D9 - device available for evaluation: no.

• Brand Name: 6.5" (17 CM) APPX 0.59 ML, SMALLBORE BIFUSE EXT SET, W/CLAVE¿, CHECK VALVE, 2 CL
• 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: 22323331
• Report Number: 9617594-2025-01335
• Device Sequence Number: 12964865
• Product Code: FMG
• UDI-Device Identifier: 00887709127166
• UDI-Public: (01)00887709127166(17)290401(10)13986471
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: B33983
• Device Lot Number: 13986471
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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