MAUDE Adverse Event Report: SURE-T PARADIGM; UNO CONTACT DETACH G29 80/6 SC1 MIMX

Lot Number 6000329

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.On 05-apr-2024, it was reported that the patient's infusion set's tubing was detached from the set connector.The site location was left leg, with the pump on the left side of the bed, next to patient.Moreover, the infusion had been used for two days.Reportedly, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was dropped with the set connected to patient's body.No further information available.

• Brand Name: SURE-T PARADIGM
• Type of Device: UNO CONTACT DETACH G29 80/6 SC1 MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19104533
• MDR Text Key: 340900333
• Report Number: 3003442380-2024-00226
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019348
• UDI-Public: 05705244019348
• Combination Product (y/n): N
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 6000329
• Date Manufacturer Received: 04/06/2024
• Patient Sequence Number: 1