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

Model Number	011-CS25
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	11/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Received one used.List #011-cs25, check valve with male/female luer lock; lot #5600058.As received an axial crack was observed at the female luer of the returned list #011-cs25, check valve with male/female luer lock; lot #5600058.The crack propagated through the gate.The sample was leak tested per product specification.There was a leak at the crack on the used sample.The reported complaint of leakage can be confirmed on the returned one used.List #011-cs25, check valve with male/female luer lock; lot #5600058 due to the crack observed on the sample.The damage observed is typical of an environmental stress cracking during use.The device history review (dhr) for lot 5600058 was reviewed and no non conformities were found that would have led to the reported complaint.
Event or Problem Description
The event involved a check valve with male/female luer lock where it was reported on the neurosurgical intensive care unit, during a round, a patient was found reactive to the medical care, hypertensive and disconnected from the respirator.The patient should have been sedated.The medical care team observed that the check-valve was cracked and that there was a flow of liquid, as hypnovel, sufentanyl and propofol were flowing on this line.This resulted in unwanted suppression of sedation, rebound of intracranial hypertension with risk of cerebral damages, even death for this patient.The valve was then changed.There was patient involvment and adverse event.Two used devices were returned for investigation and additional information received from the customer stating both these devices were used on the same patient.This captures the second of two occurrences.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16552885
• Report Number: 9617594-2023-00110
• Device Sequence Number: 2834596
• Product Code: FMG
• UDI-Device Identifier: 00840619006075
• UDI-Public: (01)00840619006075(17)260901(10)5600058
• 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,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2026
• Device Model Number: 011-CS25
• Device Catalogue Number: 011-CS25
• Device Lot Number: 5600058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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: HYPNOVEL, UNK MFR; PROPOFOL, UNK MFR; RESPIRATOR, UNK MFR; SUFENTANYL, UNK MFR
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown