MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX MICRO BORE MULTI LINE ADMIN EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MBF27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when temporarily disconnecting a bifurcate from the patient's port, the collar of the bifurcate completely broke and slid off the bifurcate.There was patient involvement, and "minimum" patient harm/adverse event reported.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9616567-2025-00025.The date of that submission was 07 feb 2025.One sample was received for evaluation.Through testing, the reported problem was confirmed.The probable cause is due to unintentional external tightening forces.The reported condition could not be attributable to the manufacturing process as an excessive force needs to be applied on the product to reproduce such condition.

• Brand Name: MEDEX MICRO BORE MULTI LINE ADMIN EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 22116692
• Report Number: 1526863-2025-00062
• Device Sequence Number: 17206173
• Product Code: FPA
• UDI-Device Identifier: 10351688510471
• UDI-Public: (01)10351688510471(17)270701(10)6025674
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K841882
• 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
• Report Date (Section B): 05/30/2025

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: Health Professional
• Device Catalogue Number: MBF27
• Device Lot Number: 6025674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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: Unknown