MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B4020
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Event occurred on an unspecified date involving a 3-way high flow stopcock w/rotating luer where the reporter stated that the patient was on high-dose pressors when the blood pressure suddenly dropped to 40¿s/20¿s.Then the provider called to room, and they came preparing to cardiovert and possibly begin cpr.It was noted that medication was leaking onto bed.They replaced leaking stopcock, and blood pressure increased to 220¿s systolic.There was adverse event and unknown delay in therapy reported as a result of this event.
Additional Manufacturer Narrative
Device has been received; however, evaluation has not been completed.
Additional Manufacturer Narrative
Investigation summary: received one (1) used non-icu medical stopcock for inspection.The configuration of the stopcock did not match the list number or other list numbers distributed by icu medical.Two (2) cracks were observed on one (1) of the female luers.The stopcock was leak tested per product specifications.There was leakage from the crack.The reported complaint could not be confirmed.The stopcock was not an icu medical device.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.Note: this complaint will be voided as the suspect device is not an icu medical product.

• Brand Name: 3-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: 22290121
• Report Number: 9617594-2025-01296
• Device Sequence Number: 8373874
• Product Code: FMG
• UDI-Device Identifier: 00887709008717
• UDI-Public: (01)00887709008717(17)291001(10)14192222
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: B4020
• Device Lot Number: 14192222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• 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: HIGH DOSE PRESSORS (MFR UNK)
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown