MAUDE Adverse Event Report: UNOMEDICAL A/S I PORT ADVANCE; I-PORT ADVANCE 6 MM 2-PACK

Model Number	MMT-100T
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11 : patient city: (b)(6), patient country: united states.Since no lot number is available, a detailed investigation, tests on reference samples or batch review cannot be conducted.Therefore, this complaint will be closed, this issue will be monitored through post marketing surveillance (pms) product trends and malfunction.If any trends picked up, this will flag on the trips and alerts according to the on market quality review (omqr) procedure.
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.On 30-september-2024, it was reported by the patient that infusion set cannula was kinked and blood in the cannula within two days of use.Infusion set was placed in abdomen.Company do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information was available.

• Brand Name: I PORT ADVANCE
• Common Device Name: I-PORT ADVANCE 6 MM 2-PACK
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 20637834
• Report Number: 3003442380-2024-31316
• Device Sequence Number: 18014523
• 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): 10/09/2024

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-100T
• Device Lot Number: UNKNOW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 11/08/2024
• 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