MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B4018
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 4-way high flow stopcock w/rotating luer where it was reported while using the 4-way stopcock for a saline bubble study (for an echocardiogram) the item leaked, causing saline and blood to spray.It was noted that the entire amount of saline/blood mixture (9 cc) "sprayed" over the patient and staff.The stopcock and all surrounding pieces were wet.Additionally, there was blood visible in the area of the stop cock between the white and the clear plastic.There was no hole, tears or any defect was noted.Additionally, the event occurred multiple times - some small leaks and 2 large ones.They had 2 injections through the stopcock without a problem; they did not move the stopcock and on the third injection that the saline sprayed over the staff.No human harm.Reported.This report captures 2 occurrences.
Additional Manufacturer Narrative
The device is not available for evaluation; however, a photo and lot number has been provided.A device history lot review is pending.
Additional Manufacturer Narrative
One photo was shared by customer, where 2 syringes are connected to the stopcock, no leaks or anomalies are observed, based on the photo.Complaint of leaks cannot be confirmed or replicated based on the evidence shared by customer.The dhr lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER
• 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: 22297434
• Report Number: 9617594-2025-01300
• Device Sequence Number: 18327477
• Product Code: FMG
• UDI-Device Identifier: 00887709008694
• UDI-Public: (01)00887709008694(17)290801(10)14117698
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K080077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: B4018
• Device Lot Number: 14117698
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NORMAL SALINE - EXCELSIOR MEDICAL.
• Patient Sex: Unknown