MAUDE Adverse Event Report: Unomedical Devices S.A de C.V Inset II; Set, Administration, Intravascular

Model Number	MMT-943A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's infusion set was leaking at the site that lead to hyperglycemia event which was treated with insulin pump on (b)(6) 2025.
Additional Manufacturer Narrative
Unomedical hereby submits this initial report as part of its complaint remediation activities conducted under a capa 2356421 and capa 2566479 in accordance with the fda action plan, which incorporates qp-ic-2026-0020 (ic retrospective complaint review) and qp-ic-2026-0024 (ic retrospective mdr review).This submission includes a retrospective reassessment of previously evaluated complaints.Unomedical is providing this supplemental 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.Imdrf cause investigation code: code c24 is not available in database to capture malfunction observed without conclusive finding.Additional information - this medical device report (mdr)is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary.Complaint investigation results: electronic quality management system search: a query was run in the electronic quality management system on 15/jul/2026 against "lot number" "6006887" and similar malfunction codes: leakage from infusion site (cannula base part/cannula) (specific cause not identified), insertion site egress - significant wetness / pooling.The lot 6006887 and failure mode are not related to any non-conformance corrective and preventive action of the same or similar nature.Similar complaints search: a query was run in the electronic quality management system on 15/jul/2026 against "lot number" criteria equal "6006887" and similar malfunction codes: leakage from infusion site (cannula base part/cannula) (specific cause not identified), insertion site egress - significant wetness / pooling.The count of complaints is 6.See attachment for similar complaints.Escalate to corrective and preventive action determination for statistical analysis.Batch record / medical device file review: the lot 6006887 was manufactured according to 4905082 version 71 and manufactured in the machine/line: inset 9, on 02/may/2024 with a total of (b)(4) units.Sub-assembly: gluing of tubing.The lot 4d04077 was manufactured according to 4905294 version 64 and manufactured in the machine/line: sc09, on 01/may/2024, with a total of (b)(4) units.The lot 4d04078 was manufactured according to 4905294 version 64 and manufactured in the machine/line: sc09, on 03/may/2024, with a total of (b)(4) units.Batch record / medical device file review: the batch record / medical device file was reviewed and showed that during the online process inspection, a flow failure was detected, triggering an extended inspection.All required in-process and final tests were completed and met specified requirements.No deviations were identified, and no maintenance events were recorded that could be related to the complaint code.Conclusion: batch record / medical device file review supports compliance with manufacturing and quality requirements; no issues related to the reported complaint were identified.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.Retain samples testing: retain samples from the relevant lot were previously tested in complaint (b)(4) on 06/jun/2025.Work instruction guidance for visual testing for complaints area version 3: all 10 samples tested passed visual inspection.Work instruction guidance for functional testing for complaints area version 2: all 5 samples tested passed air flow testing for the reported malfunction code: insertion site egress - significant wetness / pooling.All test results were within specification as documented in the attached database complaint.(b)(4) complaint test report.Pdf.Conclusion: testing did not confirm the reported issue; no nonconformance identified.Corrective and preventive action determination assessment: based on the investigation, further investigation is required because the following threshold was met.6 complaints exist for the same lot 6006887 and similar malfunctions.A child investigation has been opened: 3007480.Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number.Reporting site: 8021545.Manufacturing site: 3003442380.

• Brand Name: Inset II
• Common Device Name: Set, Administration, Intravascular
• Manufacturer (Section D): Unomedical Devices S.A de C.V; ave.fomento industrial l9 m3; parque industrial del norte; reynosa,tamps. 88736 ; MX 88736
• Manufacturer (Section G): Unomedical Devices S.A de C.V; ave.fomento industrial l9 m3; parque industrial del norte; reynosa,tamps. 88736 ; MX 88736
• Manufacturer Contact: pamela meadows ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; +1(603)247-0255
• MDR Report Key: 50187253
• Report Number: 3003442380-2026-70024
• Device Sequence Number: 10183288
• Product Code: FPA
• UDI-Device Identifier: 05705244020030
• UDI-Public: 05705244020030
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-943A
• Device Lot Number: MMT-943A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 08/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown