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

Lot Number 5399594

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 poland on (b)(6) 2024, it was reported that patient's infusion set's tubing was detached from the tubing connector.The site location was patient's abdomen (buttocks).Moreover, the infusion had been used for the second 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 INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18736213
• MDR Text Key: 336311415
• Report Number: 8021545-2024-00109
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/01/2024
• Device Lot Number: 5399594
• Date Manufacturer Received: 02/13/2024
• Patient Sequence Number: 1