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

Model Number	MMT-886
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number: (b)(4).Event occurred in spain on (b)(6) 2023, the patient reported that the infusion set's tubing came apart close to the site.The site location was patient's abdomen.Moreover, the infusion had been used for one day.Reportedly, the infusions were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: SURE-T PARADIGM
• Common Device Name: UNO CONTACT DETACH G29 80/10 PCC MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 16394769
• Report Number: 3003442380-2023-00173
• Device Sequence Number: 6375685
• Product Code: FPA
• UDI-Device Identifier: 05705244006034
• UDI-Public: 05705244006034
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 02/17/2023

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
• Device Model Number: MMT-886
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 02/17/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown