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 stated, when she slept last night, the tubing was loose from the set.The area where the set became detached was the second connector and not the site.Reportedly, the patient woke up in the morning and the infusion set had broken away from the set.The patient reported infusion set tubing came apart.Reportedly, the patient was using the infusion for 4 days.The patient was not sure about the stress or pull on the tubing, however, the pump wasn't dropped with the set connected to the body.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: COMFORT SHORT 110/13 PCC
• MDR Report Key: 8211197
• Report Number: 8021545-2018-00102
• Device Sequence Number: 16606987
• 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: 11/09/2016
• Initial Report FDA Received Date: 01/02/2019
• Patient Sequence Number: 1