MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX FOUR-WAY STOPCOCK EXTENSION; TUBING, FLUID DELIVERY

Catalog Number	MX43860
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had bonding issues; bonding coming off.The patients' arterial lines were leaking blood.There was patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.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
H6: evaluation codes updated.Device evaluation: one photo was provided by the customer.From the photo, it was observed that the tube was detached from the component stopcock.Through analysis of the photo, a probable cause could not be determined as it was observed that the solvent bonding process was present on the tube.As a result of this investigation, it was concluded that it was not possible to replicate the failure related to this complaint and the failure mode could not be attributable to the manufacturing process.A root cause for the failure mode was not possible to be determined.No dhr review was able to be completed as the lot number was not provided.

• Brand Name: MEDEX FOUR-WAY STOPCOCK EXTENSION
• 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: 20533156
• Report Number: 9616567-2024-00143
• Device Sequence Number: 6772584
• Product Code: FPK
• UDI-Device Identifier: 10351688507532
• UDI-Public: (01)10351688507532
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 02/07/2025

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: MX43860
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 01/18/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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