MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A DE C.V INSET II; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MMT-965A600
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1:(b)(6).(b)(6).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 (b)(4).
Event or Problem Description
It was reported that the patient experienced adhesive issues with infusion set, which fell off after 1-2 days of use event on (b)(6) 2026 no further information is available.

• Brand Name: INSET II
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A DE C.V; ave.fomento industrial l9 m3; parque industrial del norte; reynosa,tamps. 88736 ; MX 88736
• Manufacturer (Section G): UNOMEDICAL DEVICES S.A DE C.V; ave.fomento industrial l9 m3; parque industrial del norte; reynosa,tamps. 88736 ; MX 88736
• Manufacturer Contact: courtney smith ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; 6032470255
• MDR Report Key: 24843244
• Report Number: 3003442380-2026-85900
• Device Sequence Number: 8825997
• Product Code: FPA
• UDI-Device Identifier: 05705244020399
• UDI-Public: 05705244020399
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160648
• 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): 03/13/2026

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
• Device Model Number: MMT-965A600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/10/2026
• 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