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

Lot Number 6003325

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 austria on 15-feb-2024,the patient's mother reported that her child's infusion set's tubing came apart at the tubing connector, so the patient came down and informed her mother about the same.The site location was right side of patient's abdomen and the pump was located in mdt waistband.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.They were 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: 18756232
• MDR Text Key: 336980100
• Report Number: 3003442380-2024-00158
• Device Sequence Number: 1
• Product Code: FPA
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 6003325
• Date Manufacturer Received: 02/16/2024
• Patient Sequence Number: 1