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	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used.List #011-cs25 was returned for evaluation.As received saline residuals was found inside the returned sample.However, no additional damage or anomalies are observed, no mating device was returned for evaluation.The cracking pressure met the product specification.However, the back flow pressure test failed.Complaint of blood reflux can be confirmed.The lot history of the returned packaging was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
A2 - date of birth - the patients age was used to approximate the date of birth as (b)(6) 2005.D4 and h4 the customer reported lot# 1392454522, but this did not match any in icu medical.It is clear there was a typo.13924522 was found and matched the product reported.13924522 was used for this report.The investigation is in progress, but not yet complete.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a check valve with male/female luer lock that experienced leakage.The following issue was reported by the customer: ¿ after inserting and washing with saline, blood reflux is noted¿.The product is available for evaluation.The status of the product at the time of the event is ¿unknown¿.There was yes , patient involvement, a 19 years old patient, no adverse event / human harm.In clarification to the above description , the status of the product at the time of the event is "after inserting and washing with saline".This event lead to a delay in the start of the intervention, no medical intervention necessary following this event, this event was reported by the collaborator who used it ,the infusion was not started when the problem occur, the programming entered for the infusion was drugs for maintenance sedation and balanced electrolytics , the tubing was replaced , only the valve have been replaced ,the blood loss or reflux was not considered clinically significant, the patient's condition before and after the event was stable.In clarification, the customer confirmed that ¿there was blood leaking from the cap¿.

• 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 ; IT ; 2247062300
• MDR Report Key: 20735175
• Report Number: 9617594-2024-01635
• Device Sequence Number: 12915115
• Product Code: FMG
• UDI-Device Identifier: 00840619006075
• UDI-Public: 00840619006075
• 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
• Report Date (Section B): 12/30/2024

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: 13924522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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: 19 YR
• Patient Sex: Unknown