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 Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number (b)(4).The date of that submission was 07-feb-2025.B3.Date of event: month and year of event have been provided, but day is unknown.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 review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Event or Problem Description
It was reported that the three-way stopcocks on the a-lines caused multiple disconnections from the a-lines.The connection was not secure enough and could not be made more secure leading to disconnection.The operator of device was a health professional.There was patient involvement, and no patient harm/adverse event reported.

• 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 ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 21950753
• Report Number: 1526863-2025-00049
• Device Sequence Number: 8382418
• Product Code: FPK
• UDI-Device Identifier: 10351688507563
• UDI-Public: (01)10351688507563(17)270311(10)4457071
• 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: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: 4457071
• 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: 01/15/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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: Male