MAUDE Adverse Event Report: UNOMEDICAL A/S INSET 30; UNO INSET 30 60/13 GREY TCAP 10PK INT

Model Number	MMT-886A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: poland.
Event or Problem Description
Reference number (b)(4).Event occurred in the poland.It was reported that patient faced infusion set blockage in tubing event on 08-jul-2024.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.Per revision 21 of procedure (b)(4), a child investigation is not required to document the dhr review for a type 2 reportable complaint.However, the child was created to allow the parent record to advance to review and summary.Since it was created, the dhr review was documented within the child.Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6003954, in question was manufactured at the reynosa site.Device history record (dhr)review: the lot 6003954 was manufactured according to the work instruction (wi) version 94 and packaging in the machine multivac 10 on 11-nov-2023, with a total of (b)(4) units.Gluing tube: the sub-assembly, gluing tube of the lot 3k04575 was manufactured according to the wi version 57 and manufactured in the machine ft02, on 27-oct-2023, with a total of (b)(4) units.The review of the dhr revealed that during on-line, one sample failed the visual test.Consequently, an extended for a bent needle was raised.However, according to the sampling results, the lot was accepted.Furthermore, the overall review of the dhr confirms that all required process-related tests were completed and met the applicable requirements.No deviations were identified, and conclusion summary of complaint investigation: as a result of the following: no non-conformance (nc) was raised during production in relation to the complaint malfunction code.However, this complaint requires a further device history record (dhr) determination assessment due to findings in the dhr review associated with the complaint code.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: INSET 30
• Common Device Name: UNO INSET 30 60/13 GREY TCAP 10PK INT
• 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: 19936114
• Report Number: 3003442380-2024-19554
• Device Sequence Number: 11980799
• Product Code: FPA
• UDI-Device Identifier: 05705244019461
• UDI-Public: 05705244019461
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 10/01/2026
• Device Model Number: MMT-886A
• Device Lot Number: 6003954
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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