MAUDE Adverse Event Report: EUROMI SA CANNULAS; REUSABLES CANNULAS

Catalog Number	1214L4INF-3300
Medical Device Problem Codes	Product Quality Problem (1506); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Cannula breakage at baseplate.
Additional Manufacturer Narrative
The batch file does not show any anomaly in the execution of the manufacturing steps.The incident encountered concerns a broken cannula at the base: the base brazing step was carried out on (b)(6) 2024 by (b)(6), a trained operator.(b)(4) cannula was discarded at this stage for the following reason: clogged cannula.This reject was not related to the incident observed.No other incidents were reported at this stage, and quality control at this stage is in compliance (visual verification of the weld).In addition, a destructive test is carried out every (b)(4) cannulas, for each reference.For this reference, the last destructive test was carried out on lot 23aofi013l4, on (b)(6)2023, and is compliant.The next test is planned for lot 24aphi008ol4 (currently in production).Welding of the baseplate is a manual, unitary operation.As no other complaints have been recorded on this batch, we can conclude that this is an isolated defect.

• Brand Name: CANNULAS
• Common Device Name: REUSABLES CANNULAS
• Manufacturer (Section D): EUROMI SA; zi des plenesses; 11 rue nouvelles technologies; andrimont, 4821 ; BE 4821
• Manufacturer (Section G): EUROMI; 11 rue de nouvelles technologi; z.i. des plenesses; andrimont, B-482 1; BE B-4821
• Manufacturer Contact: lauraleen thorez ; 11 rue de nouvelles technologies; z.i. des plenesses; andrimont,, B-482-1 ; BE B-4821
• MDR Report Key: 20639073
• Report Number: 3007697975-2024-00008
• Device Sequence Number: 7488545
• Product Code: GEA
• UDI-Device Identifier: 03701416203340
• UDI-Public: 3701416203340
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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: 1214L4INF-3300
• Device Lot Number: 24APCI008L4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown