MAUDE Adverse Event Report: UNOMEDICAL UM-D INSET II; UNO INSET II 60/9 PINK TCAP 10PK INT

Model Number	1002822
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 07-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 6000822 was verified and it was found within specifications.This investigation has been updated because the malfunction code changed from eakage from infusion site (cannula base part/cannula) (specific cause not identified) to insertion site egress - trace moisture / superficial wetness.Which requires additional activities not included in the original investigation dated 15-jan-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 systemeqms search: a query was run in the eqms on 06/mar/2026 against "lot number" "6000822" and similar malfunction codes: leakage from infusion site (cannula base part/cannula) (specific cause not identified), insertion site egress - trace moisture / superficial wetness.The review confirmed that lot 6000822" and the identified failure mode are not associated with any non-conformance report ncrs or capas of the same or similar nature.Similar complaints search: a query was run in the eqms on 06/mar/2026 against "lot number" criteria equal "6000822"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 2.The complaint numbers are complaint (b)(4).Device history record dhr review: the lot 6000822" was manufactured according to work instruction wi version 65 and manufactured in the line li15 on 20/apr/2023 with a total of (b)(4) units.The sub-assembly: gluing tube lot 3d01678 was manufactured according to the wi version 55 and assembled in the line sc09, on 14-apr-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 (monthly trips and alerts).Complaint unconfirmed: following investigation, the reported failure could not be confirmed for this complaint.
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported that patient has issue with an infusion set leaking at the site after about twenty hours of use on (b)(6) 2024.No further information available.

• Brand Name: INSET II
• Common Device Name: UNO INSET II 60/9 PINK TCAP 10PK INT
• Manufacturer (Section D): UNOMEDICAL UM-D; 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: 24713271
• Report Number: 3003442380-2026-99483
• Device Sequence Number: 5740226
• Product Code: FPA
• UDI-Device Identifier: 05705244018273
• UDI-Public: 05705244018273
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032854
• 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: 03/19/2026
• Device Model Number: 1002822
• Device Lot Number: 6000822
• 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: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2023
• 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 Age: 54 YR
• Patient Sex: Female