MAUDE Adverse Event Report: UNOMEDICAL A/S SURE-T PARADIGM; UNO CONTACT DETACH G29 80/6 PCC MIMX

Model Number	MMT-866
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	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 3003442380-2024-03354 - device 1 of 2.(b)(6).
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in china.On (b)(6) 2024, the patient reported the event of infusion set tubing detachment.No further information available.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Supplemental report 01 - (b)(4).Correction: this mdr is being submitted to correct the submitted model 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: the information in this complaint (b)(4) has been evaluated.The batch 5383770 in question was manufactured at the reynosa site.Investigation process of the complaint was carried out in accordance with work instruction (wi) guidance for visual testing for complaints area version 1 and wi guidance for functional testing for complaints area version 1 for the code tubing detached from hub.Complaint investigations.Photo/sample was not provided.In order to test the product, the reference samples from the lot has been requested.Test results: visual test according to with wi version 1 on reference samples, 10 samples out 10 samples passed the test.Functional static pull of the tubing-tubing hub test according to wi version 1 on reference samples, 10 samples out 10 samples passed the test.Device history record (dhr) review: the lot 5365505 was glued according to the wi version 53, machine sc05 and sc06, with a total of (b)(4) units.Review of the dhr showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation were identified, no maintenance events were recorded.Trending: a query was run in database on 07/feb/2025 against malfunction tubing detached from hub and lot 5383770 and no another complaint have been registered in tw for the same lot 5383770 and malfunction code.Conclusion summary of the related event.Harm reportable, no defect on tests, no non-conformance (nc) raised during production and malfunction code, no further actions are required.Therefore, this issue will be monitored through the post marketing surveillance (pms) product trends and malfunction according to the on market quality review (omqr) procedure.

• Brand Name: SURE-T PARADIGM
• Common Device Name: UNO CONTACT DETACH G29 80/6 PCC MIMX
• 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: 19398619
• Report Number: 3003442380-2024-03354
• Device Sequence Number: 12703327
• Product Code: FPA
• UDI-Device Identifier: 05705244006058
• UDI-Public: 05705244006058
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: 02/11/2025
• Device Model Number: MMT-866
• Device Lot Number: 5383770
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 05/25/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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