MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" SMALLBORE EXT SET W/0.2 MICRON FILTER, BCV-CLAVE®, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B9600
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device may be available for return; however, it has not yet been received.
Event or Problem Description
The filter of a 10" smallbore ext set w/0.2 micron filter, bcv-clave®, clamp, rotating luer reportedly leaked fluids onto the patient's bed.The patient was receiving umbilical venous catheter (uvc) fluids prepared by the pharmacy.A night shift staff person discovered that the extension set filter used was leaking.The customer stated that the patient was not receiving the intravenous (iv) fluids they needed, and also were concerned with a potential infection risk with an opening into a central line.
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, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 10" SMALLBORE EXT SET W/0.2 MICRON FILTER, BCV-CLAVE®, CLAMP, ROTATING LUER
• 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: 24284611
• Report Number: 9617594-2026-00092
• Device Sequence Number: 20905382
• Product Code: FMG
• UDI-Device Identifier: 00887709014602
• UDI-Public: (01)00887709014602(17)300301(10)14357565
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: B9600
• Device Lot Number: 14357565
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UMBILICAL VENOUS CATHETER (UVC), MFR UNK; UNSPECIFIED FLUIDS, MFR UNK
• Patient Sex: Unknown