MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. I-PORT ADVANCE; I-PORT ADVANCE 6 MM 2-PACK

Model Number	MMT-100T
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4) event occurred in brazil.It was reported that the patient faced an infusion set damaged cannula event on (b)(6) 2025.No further information available.
Additional Manufacturer Narrative
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.Revision 21 of 3709030 does not require a complaint that is type 2 reportable to open a child investigation.This child investigation was opened against a previous revision of 3709030.Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 5399171, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 5399171 was manufactured according to the work instruction (wi) version 22 and manufactured in the line li19 on 05-aug-2022, with a total of (b)(4) units.Review of the device history record (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 summary of complaint investigation: as a result of the following: no non-conformance (nc) raised during production related to complaint code, no trend identified for the lot in question and malfunction code, no further actions are required.This complaint will not require further root cause investigation nor corrective and preventive action (capa) plan.Therefore, this issue will be monitored through the post market surveillance activities.

• Brand Name: I-PORT ADVANCE
• Common Device Name: I-PORT ADVANCE 6 MM 2-PACK
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave, fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., mexico 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, mexico 4320
• MDR Report Key: 23322453
• Report Number: 3003442380-2025-15253
• Device Sequence Number: 9948540
• Product Code: FPA
• UDI-Device Identifier: 05705244009356
• UDI-Public: 05705244009356
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2025

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 Expiration Date: 07/08/2025
• Device Model Number: MMT-100T
• Device Lot Number: 5399171
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2022
• 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