MAUDE Adverse Event Report: UNOMEDICAL A/S INSET GUARD; MIO ADV. GREY 60/6 PCC INT

Model Number	MMT-242
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6) patient country: spain.Since no lot number is available, a detailed investigation, tests on reference samples or batch review cannot be conducted.Therefore, this complaint will be closed, this issue will be monitored through post marketing surveillance (pms) product trends and malfunction.If any trends are picked up, this will flag on the trips and alerts according to the on market quality review (omqr) procedure.
Event or Problem Description
Reference number (b)(4).Event occured in spain.It was reported that the patient faced infusion set tubing detachment event on (b)(6) 2025.The site of detachment occurred close to the site location.The infusion set was in use for two days.No further information available.

• Brand Name: INSET GUARD
• Common Device Name: MIO ADV. GREY 60/6 PCC 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: 23578984
• Report Number: 8021545-2025-03238
• Device Sequence Number: 18517993
• Product Code: FPA
• UDI-Device Identifier: 05705244016323
• UDI-Public: 05705244016323
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173879
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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-242
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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