MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHECK VALVE WITH MALE/FEMALE LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	011-CS25
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a check valve with male/female luer lock, and it was reported that crack and leak at the level of the anti-reflux valve during the infusion.There was a loss of product.Probably, some air came into contact with the patient, but there were no embolism or neurological consequences.The nurse saw the product spill onto the floor.The leak was cleaned according to the facility's protocol.There was patient involvement.
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: 3/16/2026.Received one (1) used.List #011-cs25, check valve with male/female luer lock; lot #14505009.A crack was observed on the female luer of the check valve.2 cracks were observed on the luer.The reported complaint of a leak could be confirmed.The returned sample was tested, and a leak was observed from the female luer of the check valve.The sample was observed to have 2 cracks on the sample.The probable cause is unknown.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CHECK VALVE WITH MALE/FEMALE LUER LOCK
• 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: 24466442
• Report Number: 9617594-2026-00202
• Device Sequence Number: 18537171
• Product Code: FMG
• UDI-Device Identifier: 00840619006075
• UDI-Public: (01)00840619006075(17)300701(10)14505009
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 011-CS25
• Device Lot Number: 14505009
• 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: 04/20/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 67 KG