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	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Photos were provided by the customer.Investigation is pending.Initial reporter address: (b)(6).
Event or Problem Description
The event involved a check valve with male/female luer lock, where it was reported in the infusion line, blood returns through the non-return valve.The event occurred in the anesthesia operating room when the product was placed on the infusion line.The valve was changed.The customer stated there was non clinically significant blood loss.There was a delay in therapy due to the time to change valve and bandage.The therapy was completed.There was no drug administered, but contrast agent.The doctor had some blood on his hands.There was no medical intervention needed, just hand washing.The leak did not come into contact with the patient.The leak was cleaned up according to facility protocol with no specific kit.The patient¿s condition before, during and after the incident was under general anesthesia.The patient received the full intended dose after changing the consumable.There was patient involvement, however, no report of patient harm.
Additional Manufacturer Narrative
Received one new 011-cs25, check valve with male/female luer lock for inspection.No defects or anomalies noted.The set was primed at gravity pressure per packaging directions.The back pressure was tested per product specifications.There was no back flow observed.The reported complaint was unable to be replicated or confirmed.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to manufacturer on 4/22/2024.

• 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: 19043314
• Report Number: 9617594-2024-00368
• Device Sequence Number: 7355081
• Product Code: FMG
• UDI-Device Identifier: 00840619006075
• UDI-Public: (01)00840619006075(17)280801(10)13745518
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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: 13745518
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONTRAST, UNK MFR.; UNSPECIFIED INFUSION LINE, UNK MFR.
• Patient Sex: Unknown