MAUDE Adverse Event Report: MIO ADVANCE; UNO MIO ADV. GREY 60/6 SC1 10-PK CAN

Lot Number 6001011

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 canada on (b)(6) 2024 it was reported that patient's infusion set's tubing was disconnected inside the bandage where the tubing is attached to the body part while the patient was sleeping.The site location was patient's abdomen, with the pump on the sleeping belt.Moreover, 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.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: MIO ADVANCE
• Type of Device: UNO MIO ADV. GREY 60/6 SC1 10-PK CAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18939002
• MDR Text Key: 338066369
• Report Number: 8021545-2024-00130
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K173879
• 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: 03/20/2024

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 Lot Number: 6001011
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/20/2024
• Patient Sequence Number: 1