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

Model Number	1000282
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that infusion set tubing was leaking at the site on (b)(6) 2024 and patient experienced high blood glucose level and treated with correction bolus via pump.
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 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 e1: customer (entity) name: (b)(6) based on the available information, this event is deemed to be a reportable malfunction.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: 50450104
• Report Number: 3003442380-2026-81067
• Device Sequence Number: 9837953
• Product Code: FPA
• UDI-Device Identifier: 05705244014572
• UDI-Public: 05705244014572
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

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: 1000282
• Device Lot Number: 6007702
• 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: 08/21/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2024
• 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: 23 YR
• Patient Sex: Male