MAUDE Adverse Event Report: SURE-T PARADIGM; UNO CONTACT DETACH G29 60/6 PCC MIMX

Lot Number	5388865
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 china.On (b)(6) 2023, it was reported that the infusion set's tubing got detached.The pump was not dropped with the set connected to patient's body.No further information was available.

• Brand Name: SURE-T PARADIGM
• Common Device Name: UNO CONTACT DETACH G29 60/6 PCC MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 17966151
• Report Number: 3003442380-2023-00365
• Device Sequence Number: 6790311
• Product Code: FPA
• UDI-Device Identifier: 05705244005778
• UDI-Public: 05705244005778
• Combination Product (Y/N): N
• 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): 10/19/2023

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 Expiration Date: 04/01/2025
• Device Lot Number: 5388865
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2023
• Initial Report FDA Received Date: 10/19/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown