MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX HI-FLO 3 GANG, 4-WAY MANIFOLD; STOPCOCK, I.V. SET

Catalog Number	MX4343LM
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 nurse and rt were turning the patient and noticed a pool of propofol and fentanyl underneath the patient.On further inspection it was found that the iv manifold had a crack near the connection.Manifold changed out and patient received both propofol and fentanyl.
Additional Manufacturer Narrative
G1 - mfg contact office address, city, state and zip code, correction.H3 and h6.Codes: updated.One used device with propofol and fentanyl solution residuals was received for investigation.The customer reported issue of ¿a crack near the connection¿ was confirmed.Upon removing the four claves from the manifold, cracks were observed on two of the luers.The cracked luers were identified on the 3-way stopcocks where caps were attached.A leak was observed immediately during testing from the cracked luers.The probable cause is unknown.The causal factor of the failure reported is related to a mishandling of the product outside the manufacturer¿s control.It was confirmed during the process review that the condition reported cannot be attributable to the manufacturing process.A device history record (dhr) review could not be performed as the lot number was unknown.

• Brand Name: MEDEX HI-FLO 3 GANG, 4-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: 21882265
• Report Number: 1526863-2025-00041
• Device Sequence Number: 12921765
• Product Code: FMG
• UDI-Device Identifier: 10351688507617
• UDI-Public: (01)10351688507617
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: MX4343LM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown