MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. INSET II; UNO INSET II 60/6 SC1 BLUE MIMX

Model Number	MMT-943A
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	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(4).Patient country: slovakia.Unomedical hereby submits this initial report as part of its complaint remediation activities conducted under a corrective and preventive action (capa) plan/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 05-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 the reference samples were visually inspected and tested for flow, leak test.All test results were within specifications.The batch record 6001193 was verified and it was found within specifications.This investigation has been updated because the malfunction code changed, which requires additional activities not included in the original investigation dated 05-apr-2024.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: complaint investigation results: electronic quality management system (eqms) search: a query was run in the eqms on 04/mar/2026 against "lot number" "6001193" and similar malfunction codes: leak between tubing and site connector - detachment / significant wetness, leakage from connection between the tubing connector and the infusion set (cannula part/base piece), tubing detached from tubing-tubing connector, tubing connector is cracked, split, deformed, leakage may occur.The review confirmed that lot 6001193 and the identified failure mode are not associated with any non conformance report (ncr)s or capas of the same or similar nature.Similar complaints search: a query was run in the eqms on 04/mar/2026 against "lot number" criteria equal "6001193" and similar malfunction codes: leak between tubing and site connector - detachment / significant wetness, leakage from connection between the tubing connector and the infusion set (cannula part/base piece), tubing detached from tubing-tubing connector, tubing connector is cracked, split, deformed, leakage may occur.The number of complaints is 1.The complaint number is (b)(4).Device history record (dhr) review: the lot 6001193 was manufactured according to work instruction (wi) version 61 and manufactured in machine/line inset l8, on 05/may/2023 with a total of (b)(4) units.The sub-assembly: tube lot 3d04759 was manufactured according to the wi version 55 and assembled in machine/line spot08, on 02-may-2023, with a total of (b)(4) units.Lot 3d04760 was manufactured according to the wi version 55 and assembled in machine/line sc09, on 03-may-2023, with a total of (b)(4) units.Lot 3e01349 was manufactured according to the wi version 55 and assembled in machine/line spot sc07, on 06-may-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 wi-001031 (monthly trips and alerts).Complaint unconfirmed: following investigation, the reported failure could not be confirmed for this complaint.Final conclusion summary of complaint investigation: the investigation for this complaint was completed on 05-apr-2024 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 one related complaint for lot 6001193.No ncrs, 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
Reference number (b)(4).Event occurred in slovakia.It was reported that patient faced infusion set tubing detachment event on (b)(6) 2024.The tubing was detached close to site.The infusion set was in use for two days.No further information available.

• Brand Name: INSET II
• Common Device Name: UNO INSET II 60/6 SC1 BLUE MIMX
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave. fomento industrial l9 m3; reynosa, tamaulipas, c.p, 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 24712042
• Report Number: 3003442380-2026-99604
• Device Sequence Number: 5726385
• Product Code: FPA
• UDI-Device Identifier: 05705244020030
• UDI-Public: 05705244020030
• 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): Unknown
• 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: 04/03/2026
• Device Model Number: MMT-943A
• Device Lot Number: 6001193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown