MAUDE Adverse Event Report: EUROMI EUROMI; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	EVAMATIC INFILTRATION
Medical Device Problem Codes	Misassembled (1398); Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We can observe that the cannula was tightened with a tool.The associated scratches are not a normal phenomenon when tightening the cannula, so we assume that the surgeon is not using the correct clamping key.In addition, the luer connector has loosened, it is also assumed that it was tightened with a clamp, however the procedure indicates that this female connector must be hand-tightened.This is the use of an unsuitable tool for tightening the cannula and connector by the surgeon.
Event or Problem Description
2 cannulas with unwelded luer connector.

• Brand Name: EUROMI
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): EUROMI; 11, z.i. des plenesses; rue des nouvelles technologies; andrimont, dison B-482 1; BE B-4821
• Manufacturer (Section G): EUROMI SA; 11,z.i. des plenesses; rue des nouvelles technologies; andrimont, dison B-482 1; BE B-4821
• Manufacturer Contact: alicia robert ; 11, z.i. des plenesses; rue des nouvelles technologies; andrimont, dison B-482-1 ; BE B-4821
• MDR Report Key: 16635664
• Report Number: 3007697975-2023-00001
• Device Sequence Number: 20688732
• Product Code: GEA
• UDI-Device Identifier: 03701416202718
• UDI-Public: 3701416202718
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: 878.4800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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 Expiration Date: 03/14/2024
• Device Model Number: EVAMATIC INFILTRATION
• Device Catalogue Number: 1214L4INF-2.5300
• Device Lot Number: 22AHAI006L4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown