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

Model Number	1001682
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient faced infusion set tubing was leaking at the site event on (b)(6) 2025 and also experienced high blood glucose levels which was treated by correction injection via mdi.
Additional Manufacturer Narrative
Initial 1 of 2.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.Conclusion summary of complaint investigation: a comprehensive review was conducted, including eqms queries, similar complaint searches, medical device file review, visual evidence assessment, and capa determination.No ncrs or capas of the same or similar nature were found for lot 6008099 and related malfunction codes.Two complaints was identified for this lot however, no trend or systemic issue was detected.The manufacturing records confirmed that the lot was produced in compliance with all requirements, with no deviations or maintenance events noted.Photos were requested; however, the customer confirmed that no photos were available for analysis.Consequently, an investigation was conducted using reference samples, and no failures related to the complaint were identified.No photo evidence was provided, so the assessment was based on documentation and reference sample analysis only.Based on these results, no manufacturing or quality issues were identified.The record will be closed and monitored through routine tracking and trending.For more details, see the information under the child investigation record (b)(4).After assessment of the failure via product trending over time with control charts, the risk has been deemed as within accepted limits.No further action is required.Complaint unconfirmed: following the investigation, the complaint is unconfirmed as analyzed.Based on the available information, this event is deemed to be a 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: Inset
• 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: 50317737
• Report Number: 3003442380-2026-78207
• Device Sequence Number: 21300539
• Product Code: FPA
• UDI-Device Identifier: 05705244016682
• UDI-Public: 05705244016682
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

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: 1001682
• Device Lot Number: 6008099
• 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: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2024
• 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 Age: 19 YR
• Patient Sex: Female