MAUDE Adverse Event Report: SURE-T PARADIGM; UNO CONTACT DETACH G29 60/6 SC1 MIMX

Lot Number 6000918

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 new zealand.On (b)(6) 2024, it was reported that the infusion set's tubing got detached at the tubing connector while the patient was re-arranging the clothes.The site location was top of patient's thigh.The infusion had been used for one day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.She was unsure of stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information was available.

• Brand Name: SURE-T PARADIGM
• Type of Device: UNO CONTACT DETACH G29 60/6 SC1 MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18631717
• MDR Text Key: 334663658
• Report Number: 3003442380-2024-00135
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019317
• UDI-Public: 05705244019317
• Combination Product (y/n): Y
• PMA/PMN Number: K160648
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 6000918
• Date Manufacturer Received: 01/27/2024
• Patient Sequence Number: 1