MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; COMFORT SHORT 110/13 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
(b)(4).Event occurred in the united states.The patient reported that when he woke up, he noticed that tubing detached.The site location was at the right thigh.The infusion had been in use 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.The patient was unsure if there was stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.In the investigation it was found that the tubing was detached from the tubing-tubing connector.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: COMFORT SHORT 110/13 PCC
• MDR Report Key: 8472329
• Report Number: 8021545-2019-00115
• Device Sequence Number: 11169991
• Product Code: FPA
• UDI-Device Identifier: 05705244009165
• UDI-Public: 05705244009165
• 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: 04/09/2018
• Initial Report FDA Received Date: 04/02/2019
• Patient Sequence Number: 1