MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; COMFORT 110/17 PCC

Lot Number	UNKNOWN
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.The patient reported that a few days before this report, he had just showered in the morning and then, it was found that the infusion set's tubing had detached at the quick release.The site location was left side of patient's abdomen and the pump was located on the left side in relation to the site.The infusion had been in use for about one day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Upon investigation of the returned used device (1 set), it was found that the tubing was detached from the tubing connector.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: COMFORT 110/17 PCC
• MDR Report Key: 8784196
• Report Number: 8021545-2019-00138
• Device Sequence Number: 2038116
• Product Code: FPA
• UDI-Device Identifier: 05705244009332
• UDI-Public: 05705244009332
• 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 Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 07/12/2019
• Patient Sequence Number: 1