MAUDE Adverse Event Report: UNOMEDICAL A/S INSET GUARD; UNO EWIS BLUE 60/9 HCAP 3-PK INT

Model Number	MMT-441AH
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final (b)(4) - device 1 of 2.E1: patient city: (b)(6).Patient country: canada.Unomedical hereby submits this initial report as part of its complaint remediation activities conducted under a corrective and preventive action (capa/fda) 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-mar-2026 and investigation completed on 24-jan-2026 this medical device report (mdr )is being submitted as the initial report.Additional information - this 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 (b)(4) event description and all available information was completed, and lot number 5387790 was provided.Complaint was classified under malfunction code: infusion site leakage - trace moisture / superficial wetness.No products or pictures were returned with the complaint to aid in the investigation.Capa determination: during the investigation capa-1744122 was identified, it was opened 19-sep-2023 for leakage related complaints and bounding covers medtronic extended (ewis) products and the time period reviewed.Root cause of problem: customer complaint reporting for ewis includes a large number of reports related to leakage from the infusion set produced on serterline 1 and 2 root cause investigation identified machine serterline1 and 2 had an inadequate design for the ultrasonic welders for the welding of adhesive patch and base, based on the design of the inset guard serter, and is therefore not an ideal fit for welding ewis serters.Corrective action as a result of the investigation: (b)(4) - implementation of 100% visual inspection in serterlines.(b)(4) - process validation to review ultrasonic welding process for adhesive tape on serter line 1 and 2 (ccr-1682473).(b)(4) - review and update inset guard ramp up online inspection to include the visual inspection for snap arms damaged/broken (as applicable).D(b)(4) - review and update pfmeca for serterline 1 & 2.(b)(4)- discontinue production of ewis serters on serterline 1 and serterline 2.Summary conclusion: based on no products returned to test, and capa-1744122 investigation conclusion, the complaint will be closed as complaint unconfirmed as analyzed.
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported that the patient experienced leaks with multiple extended infusion sets at the site after less than 24 hours of use with no stress on tubing on (b)(6) 2023.No further information available.

• Brand Name: INSET GUARD
• Common Device Name: UNO EWIS BLUE 60/9 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: 24709423
• Report Number: 8021545-2026-99958
• Device Sequence Number: 5727123
• Product Code: FPA
• UDI-Device Identifier: 05705244023284
• UDI-Public: 05705244023284
• 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: 04/01/2024
• Device Model Number: MMT-441AH
• Device Lot Number: 5387790
• 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: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2022
• 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