MAUDE Adverse Event Report: SILHOUETTE PARADIGM; COMFORT SHORT 80/13 PCC

Model Number	MMT-383
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 the united states.It was reported that the infusion set's tubing was detached at the quick release while the patient was sleeping.The site location was patient's abdomen and the infusion had been used for two days.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.Moreover, the patient was unsure whether there was any 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 PARADIGM
• Common Device Name: COMFORT SHORT 80/13 PCC
• MDR Report Key: 10108665
• Report Number: 8021545-2020-00109
• Device Sequence Number: 3816439
• Product Code: FPA
• UDI-Device Identifier: 05705244008892
• UDI-Public: 05705244008892
• 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: 03/01/2022
• Device Model Number: MMT-383
• Device Lot Number: 5275211
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/02/2020
• Patient Sequence Number: 1