MAUDE Adverse Event Report: SILHOUETTE®; COMFORT CANNULA 0/17

Model Number	MMT-370600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported by the patient that infusion set's tubing was leaking at the site near the quick release.Reportedly, the tubing came apart, right where it was connected to the cannula.Moreover, it was stated that the cannula and tubing were detached at the site.Further, there was no stress or pull on the tubing and the pump was not dropped with the set-in place.No further information available.

• Brand Name: SILHOUETTE®
• Common Device Name: COMFORT CANNULA 0/17
• MDR Report Key: 9870809
• Report Number: 8021545-2020-00102
• Device Sequence Number: 2910009
• Product Code: FPA
• UDI-Device Identifier: 05705244005174
• UDI-Public: 05705244005174
• Combination Product (Y/N): N
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 02/01/2020
• Device Model Number: MMT-370600
• Device Lot Number: 5178497
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1