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

Model Number	MMT-398A
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 faced leakage at infusion set insertion site event which led to hyperglycemia (190 mg/dl) and was treated with insulin shots and 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.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: emms search: a query was run in the electronic quality management system (eqms) on 15/jul/2026 against "lot number" "6007403" and similar malfunction codes: insertion site egress - trace moisture / superficial wetness.Leakage from infusion site (cannula base part/cannula) (specific cause not identified).The lot 6007403 and failure mode are not related to any non-conformance (nc's) corrective and preventive action (capa's) of the same or similar nature.Similar complaints search: a query was run in the eqms on 15/jul/2026 against "lot number" criteria equal "6007403" and similar malfunction codes: insertion site egress - trace moisture / superficial wetness.Leakage from infusion site (cannula base part/cannula) (specific cause not identified).A query was run in the eqms on 15-jul-2026 against "lot number" criteria equal "6007403" and similar malfunction code(s): insertion site egress - trace moisture / superficial wetness.Leakage from infusion site (cannula base part/cannula) (specific cause not identified).The count of complaint are 7.The complaint numbers are: "(b)(4)", "(b)(4)", "(b)(4)"."(b)(4)", "(b)(4)", "(b)(4)", "(b)(4)".Batch record review: the lot 6007403 was manufactured according to wi (b)(4) version 79 and manufactured in machine / line: m12 on 27/may/2024 with a total of (b)(6) units.Sub-assembly: assembly the lot 4e04017 was manufactured according to the 4905245 version 27 and manufactured in the line: quick set on 26/may/2024, with a total of (b)(4) units.The lot 4e06100 was manufactured according to the 4905245 version 27 and manufactured in the line: quick set on 31/may/2024, with a total of (b)(4) units.Sub-assembly: gluing of tubing the lot 4e03145 was manufactured according to the 4905078 version 41 and manufactured in the machine / line: 04,05,08 on 24-may-2024, with a total of (b)(4) units.The lot 4e05050 was manufactured according to the 4905078 version 41 and manufactured in the machine / line: 04, on 29-may-2024, with a total of (b)(4) units.Batch record / medical device file review: the batch record / medical device file was reviewed.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: batch record / medical device file review supports compliance with manufacturing and quality requirements; no issues noted.Pump manufacturer investigation: a pump manufacturer investigation report was not available for review.Visual evidence review (no photo provided, unable to 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 - does not confirm issue: retain samples from the relevant lot were requested and tested in accordance with approved procedures: work instruction (wi) (b)(4)- guidance for visual testing for complaints area (version 3): on reference samples, 10 samples out 10 samples passed the test.All samples tested passed visual inspection.Work instruction (wi) (b)(4)- guidance for functional testing for complaints area (version 2): on reference samples, 10 samples out 10 samples passed the test.All samples tested passed functional testing for the reported malfunction code all test results were within specification as documented in the attached test report "[ 2012572 test report lot 6007403]".Conclusion: testing did not confirm the reported issue; no nonconformance identified.Based on the available information, this event is deemed to be serious injury.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: Quick Set
• 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: 50186296
• Report Number: 3003442380-2026-69622
• Device Sequence Number: 9951243
• Product Code: FPA
• UDI-Device Identifier: 05705244017962
• UDI-Public: 05705244017962
• 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: 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-398A
• Device Lot Number: 6007403
• 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: 05/27/2024
• 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