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	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device is not available for investigation.However, complaint investigation activities are still pending at this time.
Event or Problem Description
The complaint/event involved a 4-way high flow stopcock w/rotating luer.The stopcock of the device was reportedly leaking.The patient¿s mean arterial pressure (map) dropped and did not initially recover, even with titration of norepinephrine; blood pressure dropped to 70/40s c map of 40s.The patient¿s infusions were then assessed and the stopcock was identified to be leaking at that time.They tried to tighten the stopcock but it was still leaking.The stopcock was quickly changed out and then the patient¿s non-invasive blood pressure (nibp) recovered.
Additional Manufacturer Narrative
The complaint that the stopcock was leaking on item b4018 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.The customer had confirmed that there are no available incident samples nor representative samples, therefore no sister samples will be returned for evaluation.The device history record 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: 19177475
• Report Number: 9617594-2024-00498
• Device Sequence Number: 20683411
• Product Code: FMG
• UDI-Device Identifier: 00887709008694
• UDI-Public: (01)00887709008694(17)281001(10)13781156
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: B4018
• Device Lot Number: 13781156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: NON-INVASIVE BLOOD PRESSURE CUFF, MFR UNK.; NOREPINEPHRINE, MFR UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown