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

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2024

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 337746615
• Report Number: 9617594-2024-00256
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619006075
• UDI-Public: (01)00840619006075(17)280901(10)13752166
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-CS25
• Device Lot Number: 13752166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SYRINGE, UNK MFR; UNSPECIFIED CATHETER, UNK MFR