MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX MANIFOLDS; STOPCOCK, I.V. SET

Catalog Number	MX4343LM
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stop cock manifold was found to be leaking medication on to the floor.All connections were checked during safety check at the start of the shift.No loose connection or cracks were found in the manifold to explain the leakage.The issue was resolved by replacing the manifold.There was patient involvement, and no harm/adverse event reported.
Additional Manufacturer Narrative
Device evaluation: neither samples nor pictures were received for the analysis of this complaint.Due to the lot number not being provided, it was not possible to execute the dhr review for this complaint.Complaint for the failure mode could not be confirmed by investigation as no samples nor pictures 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.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record could not be completed as no lot number was received.

• Brand Name: MEDEX MANIFOLDS
• 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 ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21143342
• Report Number: 9616567-2025-00009
• Device Sequence Number: 18553174
• Product Code: FMG
• UDI-Device Identifier: 10351688507617
• UDI-Public: (01)10351688507617
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: Other
• Device Catalogue Number: MX4343LM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/30/2025
• 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
• Patient Sex: Unknown