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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.E1 initial reporter phone number: (b)(6).
Event or Problem Description
The event involved a check valve with male/female luer lock where it was reported by the customer: ¿anti-reflux cap positioned with constant blood leakage from the cap¿.The device was at first use and the customer has also stated that there were no clinical consequences.There was patient involvement, age 45 years, however no adverse event or human harm.
Additional Manufacturer Narrative
The complaint of leakage on the 011-cs25 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history for lot 13796955 was reviewed and no nonconformities were found that would have led to the reported complaint.
Event or Problem Description
Additional information received july 24, 2024.The customer stated there was a delay in starting the surgical procedure, supervision was necessary following this event.The customer became aware of this event as it was reported by collaborators.The problem occurred with the procedure in progress, estimated time of approximately 30 minutes onwards.The programming entered for the infusion was insertion of the needle and device and almost immediate infusion.The infused therapy was hydrating electrolytes and drugs for anesthetic induction.No chemotherapy.The infusion therapies and device were replaced.The blood loss or backflow were not significant due to early interception.The patient's condition before and after the event was stable.

• 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: 19392245
• Report Number: 9617594-2024-00664
• Device Sequence Number: 15403601
• Product Code: FMG
• UDI-Device Identifier: 00840619006075
• UDI-Public: (01)00840619006075(17)281001(10)13796955
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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: 13796955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2023
• 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: 45 YR
• Patient Sex: Unknown