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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
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.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.E1 initial reported (full) phone number: (b)(6).
Event or Problem Description
The complaint/event involved a check valve with male/female luer lock.It was reported that the anti-reflux cap position had constant blood leakage from the cap at the first use.There were no clinical consequences as a result of this complaint/event.
Additional Manufacturer Narrative
Received two (2) photos showing the packaging information of the product.No defects or anomalies noted.The complaint of leakage on the 011-cs25 could not be confirmed by investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record was reviewed and no nonconformities were found that would have led to the reported complaint.
Event or Problem Description
The customer provided additional information on 24jul2024 stating that there was a delay to a surgical procedure and supervision was required following the complaint/event.The problem occurred while the procedure was in progress, with an estimated time of approximately 30 minutes onwards.The programming was entered for the infusion, there was insertion of the needle and device and then almost immediate infusion.Hydrating electrolytes and drugs for anesthetic induction were the infusates in use; no chemotherapy was involved.The infusion therapies and the medical 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: 19282156
• Report Number: 9617594-2024-00574
• Device Sequence Number: 6339278
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/09/2024; 07/24/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 07/06/2024; 08/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ANESTHETIC INDUCTION DRUGS, MFR UNK.; UNSPECIFIED HYDRATING ELECTROLYTES, MFR UNK.; UNSPECIFIED NEEDLE, MFR UNK.
• Patient Age: 48 YR
• Patient Sex: Unknown