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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a check valve with male/female luer lock where it was reported by the customer the check valve was nonfunctional.The infused product does not pass, the syringe must be pushed hard.Verification of the catheter on the patient, which is functional.The patient could have been reinfused if the reporter had not tested the catheter.The valve was removed and discarded.The incident happened at the interventional preparation room.The status of the product at the time of the event is during infusion.There was patient involvement and no report of patient harm.
Additional Manufacturer Narrative
The complaint of no flow / can't prime / difficult to prime on item 011-cs25 cannot be confirmed by investigation.Since 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 probable cause cannot be determined.The device history review (dhr) lot#13752166 was reviewed and no nonconformities were found that would have led the reported condition on the complaint.E1initial reporter address: (b)(6).

• 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: 18886719
• Report Number: 9617594-2024-00256
• Device Sequence Number: 2997820
• Product Code: FMG
• UDI-Device Identifier: 00840619006075
• UDI-Public: (01)00840619006075(17)280901(10)13752166
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2024

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: 13752166
• 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: 02/12/2024
• Initial Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: SYRINGE, UNK MFR; UNSPECIFIED CATHETER, UNK MFR
• Patient Sex: Unknown