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

Catalog Number	MX9342L
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the yellow 4-way stopcock connected to the patient's ij central line broke in half and the multiple medication that were infusing through that lumen/stopcock were backflowing out of the broken stopcock onto the bed.There was patient involvement and no patient adverse event reported.

• Brand Name: MEDEX STOPCOCKS
• 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: 21143274
• Report Number: 9616567-2025-00008
• Device Sequence Number: 9097781
• Product Code: FMG
• UDI-Device Identifier: 10351688504166
• UDI-Public: (01)10351688504166
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/13/2025

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: Other
• Device Catalogue Number: MX9342L
• 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: 12/17/2024
• Initial Report FDA Received Date: 01/13/2025
• 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 Age: 42 YR
• Patient Sex: Female