MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; COMFORT SHORT 60/13 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 (b)(6).The patient reported that the infusion set tubing got detached while shopping.Reportedly, the location of detachment was at the connector.The site location was abdomen and the pump was worn on belt.The infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.The infusion had been in use for four days.Also, there was no stress or pull on the tubing and the pump wasn't dropped with the set connected to the body.The patient had faced the same issue earlier as well, two times but realized it two hours later.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: COMFORT SHORT 60/13 PCC
• MDR Report Key: 8238776
• Report Number: 8021545-2019-00100
• Device Sequence Number: 16691879
• Product Code: FPA
• UDI-Device Identifier: 05705244008564
• UDI-Public: 05705244008564
• 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: 10/05/2018
• Initial Report FDA Received Date: 01/11/2019
• Patient Sequence Number: 1