MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; COMFORT SHORT 46/13 PCC

Lot Number	5239408
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 united states.The patient's mother reported, the tubing detached from the site and detachment occurred at quick release.The set came out of the patient's body while she was sleeping.The patient was using an infusion set with serial no.(b)(4).The infusion set was being used for 4 days before this complaint.There was no stress or pull on the tubing and the pump wasn't dropped with the set connected to their body.No further information available.
Event or Problem Description
On 30-oct-2019: follow up information was submitted because result of complaint investigation of the returned used device (1 set) showed that the tubing was detached from the tubing connector.Based on the result: result and conclusion codes were updated.Unomedical reference number: (b)(4).Event occurred in united states.The patient's mother reported, the tubing detached from the site and detachment occurred at quick release on the day of this report ((b)(6) 2018).The set came out of the patient's body while she was sleeping.On (b)(6) 2018, at 12:47 pm, the patient changed the infusion set.The site location was at the outer part of right thigh and the pump was clipped to patient's right-side waist band.The patient was using an infusion set with serial no.(b)(4).The infusion set was being used for 4 days.The infusions were stored at room temperature.The patient was unsure of any stress or pull on the tubing and the pump wasn't dropped with the set connected to their body.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: COMFORT SHORT 46/13 PCC
• MDR Report Key: 8172858
• Report Number: 8021545-2018-00114
• Device Sequence Number: 19553216
• Product Code: FPA
• UDI-Device Identifier: 05705244008434
• UDI-Public: 05705244008434
• 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,Followup

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: 06/01/2021
• Device Lot Number: 5239408
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 10/30/2019
• Patient Sequence Number: 1