MAUDE Adverse Event Report: TRUSTEEL; UNO CONTACT DETACH G29 60/6TCAP 10PK INT

Model Number 1002833

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in united states.It was reported that on (b)(6) 2021, infusion set's tubing detached/broken at the site connector.Her blood glucose level was 178 mg/dl at the time of event.Moreover, on (b)(6) 2021, her blood glucose level raised, and she changed her infusion set.Moreover, they replaced the infusion set and insulin was resumed successfully.No further information available.

• Brand Name: TRUSTEEL
• Type of Device: UNO CONTACT DETACH G29 60/6TCAP 10PK INT
• MDR Report Key: 12286349
• MDR Text Key: 265366230
• Report Number: 3003442380-2021-00356
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018426
• UDI-Public: 05705244018426
• Combination Product (y/n): Y
• PMA/PMN Number: K041545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• 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
• Device Operator: No Information
• Device Expiration Date: 10/01/2023
• Device Model Number: 1002833
• Device Lot Number: 5323328
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/06/2021
• Type of Device Usage: N
• Patient Sequence Number: 1