MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 110/9 HCAP 1-PK INT

Lot Number 5413270

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 a 12-year-old male child patient's infusion set's tubing got disconnected from blue connector hub of infusion set.According to the complaint investigation performed on the reference samples,it was found that 1 of 5 sample was found with the glue in the tubing connector was missing and a drop of glue was found misplaced on tubing connector side.No further information was available.

• Brand Name: MEDTRONIC EXTENDED
• Type of Device: UNO EWIS BLUE 110/9 HCAP 1-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18666301
• MDR Text Key: 334838176
• Report Number: 8021545-2024-00107
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K210544
• 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: 02/08/2024

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: 5413270
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/08/2024
• Patient Sequence Number: 1