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

Model Number	MMT-431AH
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient faced an event where leakage was at the 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 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.Imdrf cause investigation code: code b24 is not available in database to capture event history log review.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: review of complaint record database (b)(4) event description and all available information was completed, and lot number: 5385904 was provided.Complaint was classified under malfunction code infusion site egress â " - trace moisture / superficial wetness.No products or pictures were returned with the complaint to aid in the investigation.A query was run in the electronic quality management system (eqms) on 05-mar-2026 against "lot number" "5385904" and similar malfunction code(s).Infusion site egress â" - trace moisture / superficial wetness.Infusion site leakage - trace moisture / superfical wetness.Infusion site leakage â"- trace moisture / superfical wetness.Leakage infusion site (cannula base part/cannula) (specific cause not identified).Leakage from infusion site (cannula base part/cannula) (specific cause not identified).Record database (b)(4) were identified for this lot and similar related issues.A non-conformance (nc) / corrective and preventive action (capa)query search was run in the eqms system performed on 05-mar-2026 against "lot/batch number" "5385904".No records were found.Dhr review: the device history record (dhr) for lot: 5385904 was reviewed.Review of the dhr showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation was identified, nor maintenance events were recorded related to complaint code.Conclusion of complaint investigation: lot no.5385904 was provided, however, as the complaint is categorized as a reportable with no harm reported and no issues were found during eqms search and dhr review: no visual inspection is required to be performed.No retain sample testing is required to be conducted.No further assessment will be made regarding potential product performance issues, component integrity, or manufacturing defects.Capa determination: based on the available information, no further investigation is required nor capa plan is needed.The record will be closed and monitored through tracking and trending (monthly trips and alerts).Summary conclusion: based on the available information, the investigation has been performed, and the complaint could not be confirmed as analyzed.Therefore, the complaint is closed based on the event description and all information made available.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: pamela meadows ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; +1(603)247-0255
• MDR Report Key: 50126068
• Report Number: 8021545-2026-32369
• Device Sequence Number: 10527621
• Product Code: FPA
• UDI-Device Identifier: 05705244023161
• UDI-Public: 05705244023161
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2026

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 Expiration Date: 05/01/2024
• Device Model Number: MMT-431AH
• Device Lot Number: 5385904
• 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: 07/17/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• 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