MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. SILHOUETTE; UNO COMFORT SHORT CANNU 0/13 MCNI

Model Number	MMT-369600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: canada.
Event or Problem Description
Reference number: (b)(4).Event occurred in canada.It was reported that patient faced an infusion set tubing detached event on 29-may-2025 from site.The insertion site was the upper site area at abdomen.Infusion set was used for couple of hours.No further information available.
Additional Manufacturer Narrative
Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions h11: investigation summary the information in this (b)(4) has been evaluated.The batch 6001659 in question was manufactured at the reynosa site.Investigation process of the complaint was carried out in accordance with work instruction (wi) guidance for visual testing for complaints area version 3 and wi guidance for functional testing for complaints area version 2 for the tubing connector detached from infusion set (cannula part/base piece) photo/sample was not provided.In order to test the product, the reference samples from the lot have been requested.Test results: visual test according to wi version 3 on reference samples, 10 samples out 10 samples passed the test.Functional test 1 static pull base-connector according to wi version 2 on reference samples, the static test for the base-connector could not be performed because the product is a cannula-only model.Functional test 1 click according to wi version 2 on reference samples, click test could not be performed because the product is a cannula-only model.Device history record (dhr) review: the lot 6001659 was manufactured according to the wi version 14 and packaging in the machine 14, on 06/jun/2023, with a total of (b)(4) units.Cannula: the lot 3e05868 was assembled according to the wi version 11 on-line inspection for assembly on 01-jun-2023, with a total of (b)(4) units each.The lot 3e03909was assembled according to the wi version 11 on-line inspection for assembly on 25-may-2023, with a total of (b)(4) units each.The lot 3f01340was assembled according to the wi version 11 on-line inspection for assembly on 08-jun-2023, with a total of (b)(4) units each.Review of the dhr showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation were identified; no maintenance events were recorded.Trending: a query was run in database on 24/jun/2025 against malfunction code tubing connector detached from infusion set (cannula part/base piece) and lot 6001659 and one more complaint have been registered in database for the same lot and malfunction code.Conclusion summary of the related event: as a result of the following: no defect on the visual inspection for reference samples, no harm reported, no non-conformance (nc) raised during production, no other complaint received on the lot in question and reported malfunction.No further actions are required.This complaint will not require further root cause investigation nor capa plan.Therefore, this issue will be monitored through the post market surveillance activities.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: SILHOUETTE
• Common Device Name: UNO COMFORT SHORT CANNU 0/13 MCNI
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave, fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., mexico 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 22173234
• Report Number: 3003442380-2025-10472
• Device Sequence Number: 9263242
• Product Code: FPA
• UDI-Device Identifier: 05705244005112
• UDI-Public: 05705244005112
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/05/2026
• Device Model Number: MMT-369600
• Device Lot Number: 6001659
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown