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

Model Number	MMT-923A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced high blood glucose and leakage at infusion site on (b)(6) 2023.
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 (b)(4) (ic retrospective complaint review) and (b)(4) (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.Additional information - this electronic medical device report (emdr) 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 (eqms)search: a query was run in the eqms on 16/jul/2026 against "lot number" 6002306 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 6002306 the identified failure mode is not associated with any nonconforming reports (ncr) or corrective and preventive action (capa) of the same or similar nature.The complaint can be closed referencing the investigation as it addresses the malfunction.Similar complaints search - threshold not met or exceeded: a query was run in the eqms on 16/jul/2026 against "lot number" criteria equal "6002306" and similar malfunction codes leakage from infusion site (cannula base part/cannula) (specific cause not identified), insertion site egress - trace moisture/superficial wetness.The count of complaints is 1.The complaint numbers is "(b)(4)".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 (no further 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) complaint unconfirmed: following investigation, the reported complaint is unconfirmed as analyzed.Conclusion summary of complaint investigation: as a result of the following: a comprehensive review was conducted, including eqms queries, similar complaint searches, visual evidence assessment, and capa determination.No ncrs or capa's of the same or similar nature were found for lot 6002306 and related malfunction code insertion site egress - trace moisture / superficial wetness.One complaint was identified for this lot, but no trend or systemic issue was detected.No photo evidence was provided, so the assessment was based on documentation only.Based on these results, no manufacturing or quality issues were identified, and no further investigation is required.The record will be closed and monitored through routine tracking and trending per wi(monthly trips and alerts).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: 50112778
• Report Number: 3003442380-2026-64207
• Device Sequence Number: 13342437
• Product Code: FPA
• UDI-Device Identifier: 05705244019942
• UDI-Public: 05705244019942
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/15/2026

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 Expiration Date: 06/08/2026
• Device Model Number: MMT-923A
• Device Lot Number: 6002306
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/03/2026
• Date Device Manufactured: 07/10/2023
• 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