MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. INSET II; UNO INSET II 80/6 SC1 PINK MIMX

Model Number	MMT-925A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final mdr (b)(4) - device 3 of 5.E1: patient city: (b)(6).Patient country: (b)(6).Unomedical hereby submits this initial report as part of its complaint remediation activities conducted under a corrective and preventive action (capa)/fda action plan.This submission includes a retrospective reassessment of previously evaluated complaints.Unomedical is providing this initial information in accordance with the reporting requirements set forth in 21 cfr part 803.Any fields left blank indicate that the information is unknown, unavailable, or remains unchanged based on the review completed on 25-feb-2026 and investigation completed on 18-mar-2026 this medical device report (mdr) is being submitted as the initial report.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: this investigation has been updated because the malfunction code changed, which requires additional activities not included in the original investigation dated 25-sep 2023.The original investigation remains valid and has not been modified.As part of this reassessment, the following elements were added to align with current investigation requirements: the reference samples were visually inspected and tested for flow and leak.All test results were within specifications.The batch record 5408467 was verified and found it within specifications.The reference samples were visually inspected and tested for flow, leak test.All test results were within specifications.The batch record 5408467 was verified and it was found within specifications.Complaint investigation results: electronic quality management system (eqms) search: a query was run in the eqms on 18/mar/2026 against lot number 5408467 and similar malfunction codes: leakage from infusion site (cannula base part/cannula) (specific cause not identified), insertion site egress - trace moisture / superficial wetness.Similar complaints search: a query was run in the eqms on 18/mar/2026 against lot number criteria equal 5408467 and similar malfunction codes: leakage from infusion site (cannula base part/cannula) (specific cause not identified), insertion site egress - trace moisture / superficial wetness the number of complaints is (b)(4).The complaint numbers are complaint (b)(4).Device history record (dhr) review: the lot 5408467 was manufactured according to work instruction (wi) and manufactured in the machine / line: 6, on 15/jan/2023 with a total of (b)(4) units.The sub-assembly : gluing of tube lot 5413670 was manufactured according to the work instruction (wi) and assembled in the machine / line: sc 02 on 08-jan-2023, with a total of (b)(4) units.Lot 5413671 was manufactured according to the work instruction (wi) and assembled in the machine / line: sc 02 on 09-jan-2023, with a total of (b)(4) units.The device history record (dhr) was reviewed in accordance with applicable procedures.All required in-process and final tests were completed and met specified requirements.No deviations were identified, and no maintenance events were recorded that relate to the complaint code.Conclusion: dhr review supports compliance with manufacturing and quality requirements; no issues noted.Visual evidence review: no photo was provided to support visual confirmation of the reported issue.Conclusion: unable to perform visual verification; assessment based on available documentation only.Capa determination assessment - conclusion summary of complaint investigation: based on the investigation, no further investigation is required.The record will be closed and monitored through tracking and trending per work instruction (wi) (monthly trips and alerts).The investigation for this complaint was previously completed on: 25-sep- 2023.Under child complaint investigation record: (b)(4).The investigation has been revised to reflect the updated malfunction code and new reportability requirements.The original investigation remains valid and has not been modified.As part of this reassessment, an updated eqms search was performed which identified two related complaints for lot: 5408467.No non-conformance report, capas, trends, or systemic issues were found.As required under the updated reportability criteria, a full device history record (dhr) review was conducted.All in process and final inspections met specification requirements, and no deviations, rework activities, or maintenance events associated with the malfunction were identified.No visual evidence was available to support confirmation of the reported issue.No photo evidence was provided, so the assessment was based on documentation only.Based on the expanded investigation including updated eqms searches and the dhr review no manufacturing or quality issues were identified.The record will be closed and monitored through tracking and trending per work instruction (wi) (monthly trips and alerts).
Event or Problem Description
Refrence number (b)(4).Event occurred in australia.It was reported that the patient experienced leakage at the infusion site on (b)(6) 2023.No further information available.

• Brand Name: INSET II
• Common Device Name: UNO INSET II 80/6 SC1 PINK MIMX
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave. fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p, 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 24701538
• Report Number: 3003442380-2026-99961
• Device Sequence Number: 10176512
• Product Code: FPA
• UDI-Device Identifier: 05705244019973
• UDI-Public: 05705244019973
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160648
• 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
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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: Lay User/Patient
• Device Expiration Date: 12/01/2025
• Device Model Number: MMT-925A
• Device Lot Number: 5408467
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2023
• 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