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 No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient's mother reported that on (b)(6) 2021, her (b)(6) year-old son's infusion set's tubing detached/broken at site connector.At the time of the event, his blood glucose level was 200 mg/dl, after his breakfast with high sugar.Moreover, the patient's mother assisted him to give a correction bolus via pump.Further, 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
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12932056
• MDR Text Key: 281738462
• Report Number: 3003442380-2021-00781
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/01/2023
• Device Model Number: 1002833
• Device Lot Number: 5314359
• Date Manufacturer Received: 11/24/2021
• Patient Sequence Number: 1