MAUDE Adverse Event Report: UNOMEDICAL UM-D SURE-T PARADIGM; UNO CONTACT DETACH G29 80/10 PCC MIMX

Model Number	MMT-886
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that patient faced infusion set tube blockage.Troubleshooting confirmed that the blockage was in the tube.This event occurred on (b)(6) 2025.No further information available.
Additional Manufacturer Narrative
E1: patient city: (b)(6), patient country: united states.

• Brand Name: SURE-T PARADIGM
• Common Device Name: UNO CONTACT DETACH G29 80/10 PCC MIMX
• Manufacturer (Section D): UNOMEDICAL UM-D; ave. fomento industrial l9 m3; parque industrial del norte; reynosa , tamps., 88736 ; MX 88736
• Manufacturer Contact: ave. fomento industrial l9 m3; parque industrial del norte; reynosa , tamps., 88736
• MDR Report Key: 21418502
• Report Number: 3003442380-2025-01740
• Device Sequence Number: 7775113
• Product Code: FPA
• UDI-Device Identifier: 05705244006034
• UDI-Public: 05705244006034
• Combination Product (Y/N): Y
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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: 01/31/2022
• Device Model Number: MMT-886
• Device Lot Number: 5270857
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2019
• 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