MAUDE Adverse Event Report: UNOMEDICAL A/S I PORT ADVANCE; I-PORT ADVANCE 9 MM

Model Number	MMT-101
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united kingdom.It was reported that on (b)(6) 2024 the patient experienced an issue with the i-port not being inserted properly and not staying in place.The patient is using the i-port advance to deliver insulin for treating diabetes mellitus.The i-port advance has been in use for 2 hours.The patient reported that the i-port has a slight bend.The patient was advised that a longer cannula may bend against muscle on lean patients and that if the needle is removed when the injection port is not flush with the skin, it can lose rigidity and support for the cannula.No further information available.

• Brand Name: I PORT ADVANCE
• Common Device Name: I-PORT ADVANCE 9 MM
• 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: 19491731
• Report Number: 3003442380-2024-07003
• Device Sequence Number: 15578524
• Product Code: FOZ
• UDI-Device Identifier: 05705244009417
• UDI-Public: 05705244009417
• 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): 06/07/2024

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-101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 06/07/2024
• 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