MAUDE Adverse Event Report: SILHOUETTE; UNO COMFORT SHORT CANNU 0/13 MCNI

Model Number	MMT-369600
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 (b)(6).On (b)(6) 2021, it was reported that patient's infusion set's tubing came apart at the insertion site and skin.The patient's blood glucose level was 8.5 mmol/l.The site location was right side of the patient's abdomen and the pump was located on the hip and belt line.The infusion had been used for less than 24 hours.Reportedly, the infusions were stored in the drawer, but it was hot these days.Reportedly, 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: SILHOUETTE
• Common Device Name: UNO COMFORT SHORT CANNU 0/13 MCNI
• MDR Report Key: 12141494
• Report Number: 8021545-2021-00137
• Device Sequence Number: 4215784
• Product Code: FPA
• UDI-Device Identifier: 05705244005112
• UDI-Public: 05705244005112
• 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

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 Expiration Date: 07/01/2023
• Device Model Number: MMT-369600
• Device Lot Number: 5328797
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/09/2021
• Patient Sequence Number: 1