MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX SMALL BORE EXTENSION SET W/ THREE-WAY STOPCOCK; TUBING, FLUID DELIVERY

Catalog Number	MX43660
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.H3.Reason device not evaluated by mfg: other; device was 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 cardiovascular intensive care unit experienced four instances over a few days where the device broke at the connection between the tubing pigtail and the 3-way stopcock.These breaks resulted in blood spills on the patient, their beds, and the floors.The event occurred on (b)(6) 2025 at 5 pm during use on the patient.There was medication being used with the product and there was delay in therapy.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
This complaint was incorrectly filed under this registration number, please reference mrn 1526863-2025-00033-00 for details pertinent to this event.

• Brand Name: MEDEX SMALL BORE EXTENSION SET W/ THREE-WAY STOPCOCK
• Common Device Name: TUBING, FLUID DELIVERY
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21335250
• Report Number: 9616567-2025-00024
• Device Sequence Number: 15609260
• Product Code: FPK
• UDI-Device Identifier: 10351688507563
• UDI-Public: (01)10351688507563
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: MX43660
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/09/2025
• 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