MAUDE Adverse Event Report: UNOMEDICAL A/S Inset Guard; Set, Administration, Intravascular

Model Number	MMT-432A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient faced infusion sets falling off due to heat event on (b)(6) 2026.
Additional Manufacturer Narrative
Imdrf investigation findings code c20 (no findings available) has been selected, as code c24 is not available in the database to capture (malfunction observed without conclusive finding).Imdrf cause conclusions code d16 (conclusion not yet available) has been selected, as code d1501 is not available in database to capture (cause linked to device but unable to trace more specifically).Initial 1 of 2.E1: (b)(6).Imdrf cause investigation code: code c24 is not available in database to capture malfunction observed without conclusive finding.Imdrf cause conclusions code: code d1501 is not available in database to capture cause linked to device but unable to trace more specifically.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: investigation of complaint record database (b)(4) was performed based on the event description, lot number, and the assigned malfunction code adhesive patch completely detaches during use- detachment / significant wetness.Upon review of the electronic quality management system (eqms) and related records, a capa related to adhesive issues was identified.Corrective and preventive action (capa)s-2010953 was opened for adhesive related complaints.An analysis of adhesive complaints from january 2024 until october 2025 was performed as part of the investigation.Root cause of problem: conclusion of the investigation showed the ewis instructions for use (ifu) does not provide adequate information relating to preparation of the skin when in hot and humid environments and the design verification data is lacking peel-test data along with validated test methods to quantify adhesion performance.Corrective action as a result of the investigation: corrective actions taken to update the ewis ifu and complete test method validation and verification testing.Is complaint confirmed.Based on the information provided in the complaint and capa-2010953 investigation conclusion, the complaint will be closed as complaint confirmed by accurate description of malfunction and/or harm.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: 8021545.

• Brand Name: Inset Guard
• Common Device Name: Set, Administration, Intravascular
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320
• Manufacturer Contact: armando cuello ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; +1(603)247-0255
• MDR Report Key: 50942048
• Report Number: 8021545-2026-0062051
• Device Sequence Number: 9589165
• Product Code: FPA
• UDI-Device Identifier: 05705244022713
• UDI-Public: 05705244022713
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210544
• 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): 06/10/2026

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 Model Number: MMT-432A
• Device Lot Number: 6015076
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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