MAUDE Adverse Event Report: VARISOFT; COMFORT SHORT 60/13 TCAP

Model Number	1000284
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 three times in the past three weeks, when she inserted a new cartridge and infusion set, everything seemed fine.Then within 4-24 hours, she noticed that the infusion set's tubing broke away from the clip that is inserted into the cannula.Therefore, first event occurred on (b)(6) 2020, second and third event on (b)(6) 2020, respectively.She did not notice any damage to the infusion sets when the package was first opened.Moreover, the patient was using humalog insulin type.Further, she replaced the infusion set and insulin was resumed successfully.No further information available.

• Brand Name: VARISOFT
• Common Device Name: COMFORT SHORT 60/13 TCAP
• MDR Report Key: 10383900
• Report Number: 8021545-2020-00111
• Device Sequence Number: 11231555
• Product Code: FPA
• UDI-Device Identifier: 05705244014695
• UDI-Public: 05705244014695
• 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 Expiration Date: 12/01/2022
• Device Model Number: 1000284
• Device Lot Number: 5299816
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/10/2020
• Patient Sequence Number: 1