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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was leaking in manifolds during the infusion was performed on the patient.The nurse discovered the leak when the patient was decompensated.The patient was eventually placed on va ecmo.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
D3, g1: corrected.H6: updated.H3: one picture was provided by the customer for the analysis of this complaint.The picture provided by the customer only shows the identification of the product.It cannot be analyzed the condition reported through the picture provided.Complaint for the failure mode could not be confirmed by investigation as neither pictures or samples were provided by the customer.Without the return of the used samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.

• 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 aleman; apodaca OH CP666 03; MX CP66603
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 21777785
• Report Number: 1526863-2025-00028
• Device Sequence Number: 15431232
• Product Code: FMG
• UDI-Device Identifier: 10351688507686
• UDI-Public: (01)10351688507686(17)270129(10)4447246
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: MX4315LM
• Device Lot Number: 4447246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 59 YR
• Patient Sex: Unknown
• Patient Race: White