MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; UNO COMFORT 60/17 PCC MINI

Model Number	MMT-378
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 the united states.On (b)(6) 2021, it was reported that the patient's infusion set leaked at the tubing as it came apart.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: UNO COMFORT 60/17 PCC MINI
• MDR Report Key: 12559449
• Report Number: 8021545-2021-00153
• Device Sequence Number: 872192
• Product Code: FPA
• UDI-Device Identifier: 05705244008755
• UDI-Public: 05705244008755
• Combination Product (Y/N): Y
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2021

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: No Information
• Device Model Number: MMT-378
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/01/2021
• Usage of Device: N
• Patient Sequence Number: 1