MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A DE C.V I-PORT ADVANCE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	MMT-100
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: netherlands.E1:name: (b)(6).Country: united states of america.(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: reporting site: 8021545.Manufacturing site: 3003442380.
Event or Problem Description
It was reported that the patient faced an event where tape did not stick on (b)(6) 2026.

• Brand Name: I-PORT ADVANCE
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: pamela meadows ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; 6032470255
• MDR Report Key: 25636088
• Report Number: 3003442380-2026-39069
• Device Sequence Number: 9735869
• Product Code: FOZ
• UDI-Device Identifier: 05705244009394
• UDI-Public: 05705244009394
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K120337
• 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): 05/27/2026

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 Model Number: MMT-100
• Device Lot Number: 6012451
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2025
• 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