MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX HI-FLO 5-GANG, 3 WAY MANIFOLD; STOPCOCK, I.V. SET

Catalog Number	MX4315LM
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.H3: device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the manifold on a cardiovascular intensive care unit (cvicu) patient was found to have a leak.The patient¿s blood pressure dropped significantly and went into ventricular fibrillation (v-fib) within 15-20 minutes of the incident.The therapies used on the patient at the time of the event was cardiac drugs.
Additional Manufacturer Narrative
H6.Codes: updated.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: MEDEX HI-FLO 5-GANG, 3 WAY MANIFOLD
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 21882938
• Report Number: 1526863-2025-00042
• Device Sequence Number: 7865353
• Product Code: FMG
• UDI-Device Identifier: 10351688507686
• UDI-Public: (01)10351688507686
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: MX4315LM
• Device Lot Number: UNKNOWN
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male