MAUDE Adverse Event Report: VARISOFT; UNO COMFORT SHORT 60/13 TCAP 10PK INT

Model Number 1002827

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states it was reported that on (b)(6) 2021, the patient's infusion set's tubing detached/broken at site connector prior to insertion.Further, they replaced the infusion set and insulin was resumed successfully.No further information available.

• Brand Name: VARISOFT
• Type of Device: UNO COMFORT SHORT 60/13 TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12883396
• MDR Text Key: 281342459
• Report Number: 8021545-2021-00173
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018693
• UDI-Public: 05705244018693
• Combination Product (y/n): Y
• PMA/PMN Number: K162812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2021

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
• Device Expiration Date: 07/01/2023
• Device Model Number: 1002827
• Device Lot Number: 5322017
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 11/29/2021
• Patient Sequence Number: 1