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 Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dyspnea (1816); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had an issue with bent cannula and experienced symptoms of nausea, vomiting, abdominal pain, and difficulty breathing on (b)(6) 2025 associated with high blood glucose and positive ketones.
Additional Manufacturer Narrative
Unomedical hereby submits this initial report as part of its complaint remediation activities conducted under a capa 2356421 and capa 2566479 in accordance with the fda action plan, which incorporates (b)(4) (ic retrospective complaint review) and (b)(4) (ic retrospective mdr review).This submission includes a retrospective reassessment of previously evaluated complaints.Unomedical is providing this supplemental 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 e1: patient city: ordu.Patient country: turkey.Name: medtronic minimed.Country: united states of america.Street: 18000 devonshire street.City: northridge.State: california.Zip code: 91325 - 1219.Additional information - this medical device report (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: a complaint investigation was conducted based on the event description and the assigned malfunction code.Soft cannula bent/kinked/crimped after removal - reduced flow.Additional information was requested to support the investigation; however, a lot number information was not provided.No device, device components, or other visual or physical evidence was made available for evaluation.Consequently, visual inspection, retain-sample testing, or the assessment of potential product performance issues, component integrity, or manufacturing defects could not be performed.In response to the complaint and due to the absence of a specific lot number, a high-level investigation was conducted for the i-port advance product family and the assigned malfunction.The investigation encompassed an electronic quality management system (eqms) search, assessment of complaint trends, and the review of risk management files.No systemic issues were identified.Please refer to the attached memo for full details: i-port advance (cannula) enclosure 1 eqms search results.Enclosure 2 maintanence results.Enclosure 3 raw data for complaint trending.Capa determination: based on the investigation, no further action is required.The record will be closed and monitored through tracking and trending per work instruction (wi) (monthly trips and alerts).Complaint investigation - conclusion: due to the absence of a lot number and returned product, the investigation was limited to a high-level review of the i-port advance product family, including an eqms search, complaint trending, and review of applicable risk management documentation.No evidence of a systemic issue was identified.No further action is required at this time, and the record will be closed with continued monitoring through routine tracking and trending.The record may be reassessed if additional information becomes available.Complaint unconfirmed: following investigation, the reported failure could not be confirmed for this complaint.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.

• 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: courtney smith ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; 6032470255
• MDR Report Key: 25514388
• Report Number: 3003442380-2026-34304
• Device Sequence Number: 15964985
• Product Code: FOZ
• UDI-Device Identifier: 05705244009394
• UDI-Public: 05705244009394
• Combination Product (Y/N): N
• 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): 05/30/2026

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: 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: 05/30/2026
• Initial Report FDA Received Date: 06/16/2026
• 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