MAUDE Adverse Event Report: UNOMEDICAL A/S INSET GUARD; UNO EWIS BLUE 60/6 HCAP 3-PK INT

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	09/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that the patient experienced leakage at the site on (b)(6) 2023.No further information available.
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: the united states.Unomedical hereby submits this initial report as part of its complaint remediation activities conducted under a corrective and preventive action (capa)/fda action plan.This submission includes a retrospective reassessment of previously evaluated complaints.Unomedical is providing this initial 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 based on the review completed on 25-feb-2026 and investigation completed on 16-mar-2026 this medical device report (mdr) is being submitted as the initial report.Complaint investigation results: review of complaint record database (b)(4) event description and all available information was completed, and lot number 5387786 was provided.Complaint was classified under malfunction code: infusion site egress trace moisture / superficial wetness.A query was run in the electronic quality management system (eqms) on 16-mar-2026 against lot number 5387786 and similar malfunction code(s).Infusion site egress trace moisture / superficial wetness.Infusion site leakage trace moisture / superfical wetness.Infusion site leakage 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) no records were identified for this lot and similar related issues.A nc/capa query search was run in the eqms system performed on 16-mar-2026 against lot/batch number 5387786.No records were found.Device history record (dhr) review: the device history record (dhr) for lot 5387786 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.5387786 was provided, however, as the complaint is categorized as a reportable with low 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).Root cause of problem: n/a - this complaint did not require escalation to capa, therefore no further root cause investigation has been completed.Corrective action as a result of the investigation: n/a - this complaint did not require escalation to capa, therefore no capa plan is available.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.

• Brand Name: INSET GUARD
• Common Device Name: UNO EWIS BLUE 60/6 HCAP 3-PK INT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 24701343
• Report Number: 8021545-2026-99909
• Device Sequence Number: 18751771
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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: 5387786
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/26/2026
• 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