MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE PARADIGM; UNO COMFORT SHORT 110/13 PCC MINI

Model Number	MMT-382
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: china.
Event or Problem Description
Reference number (b)(4).Event occurred in china.On 18-july-2024 it was reported that the patient faced an event of infusion set tubing detachment.The pump was not dropped with the set connected to the body.No further information available.
Additional Manufacturer Narrative
Supplemental report 01 - mdr (b)(4).Correction: this mdr is being submitted to correct the submitted lot number, expiration date under d4 and manufacturing date under h4.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: complaint investigation results: electronic quality management system (eqms) search.A query was run in the eqms on (b)(6) 2025 against "lot number 5402847 and similar malfunction codes: tubing connector detached from infusion set (cannula part/base piece), for new code creation.The review confirmed that lot 5402847 and the identified failure mode are not associated with any ncrs or capas of the same or similar nature.Similar complaints search: a query was run in the eqms on (b)(6) 2025 against "lot number" criteria equal 5402847 and similar malfunction codes : tubing connector detached from infusion set (cannula part/base piece), for new code creation.The count of complaint is 1.The complaint number is (b)(4).Device history record (dhr) review: the lot 5402847 was manufactured according to the work instruction (wi) version 12 and packaging in the multivac m10 on 03-oct-2022, with a total of (b)(4) units.The sub-assembly: gluing of tubing lot 5404272 was manufactured according to the wi version 8 and manufactured in the machine lc01, on 29-sep-2022, with a total of (b)(4) units.The device history record (dhr) was reviewed in accordance with applicable procedures.All required in-process and final tests were completed and met specified requirements.No deviations were identified, and no maintenance events were recorded that relate to the complaint code.Conclusion: dhr review supports compliance with manufacturing and quality requirements; no issues noted.Visual evidence review: no photo was provided to support visual confirmation of the reported issue.Conclusion: unable to perform visual verification; assessment based on available documentation only.Corrective and preventive action (capa) determination assessment - conclusion summary of complaint investigation: based on the investigation, no further investigation is required.The record will be closed and monitored through tracking and trending.Conclusion summary of complaint investigation: as a result of the following a comprehensive review was conducted, including eqms queries, similar complaint searches, device history record review, visual evidence assessment, and capa determination.No ncrs or capas of the same or similar nature were found for lot 5402847 and related malfunction codes for tubing detachment.One complaint was identified for this lot, but no trend or systemic issue was detected.The manufacturing records confirmed that the lot was produced in compliance with all requirements, with no deviations or maintenance events noted.No photo evidence was provided, so the assessment was based on documentation only.Based on these results, no manufacturing or quality issues were identified, and no further investigation is required.The record will be closed and monitored through routine tracking and trending.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: SILHOUETTE PARADIGM
• Common Device Name: UNO COMFORT SHORT 110/13 PCC MINI
• 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: 20060894
• Report Number: 3003442380-2024-22500
• Device Sequence Number: 12885719
• Product Code: FPA
• UDI-Device Identifier: 05705244009165
• UDI-Public: 05705244009165
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162812
• 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): 12/16/2025

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: 09/01/2025
• Device Model Number: MMT-382
• Device Lot Number: 5402847
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 08/25/2024
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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