MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 80/9 HCAP 10PK INT

Lot Number 6002437

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 (b)(6) 2023, it was reported that patient's infusion set's tubing got detached at the insertion site (blue plastic) when the patient woke up.The site location was patient's leg outer thigh, with the pump located on the waistband.Moreover, the infusion had been used for five days.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 dropped with the set connected to patient's body.Currently, the patient's blood glucose level was 176 mg/dl.According to the complaint investigation performed on the used device (1 set), it was found that, the infusion set tubing was detached from the connector.No further information available.

• Brand Name: MEDTRONIC EXTENDED
• Type of Device: UNO EWIS BLUE 80/9 HCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18755183
• MDR Text Key: 336311884
• Report Number: 8021545-2024-00113
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 6002437
• Date Manufacturer Received: 02/12/2024
• Patient Sequence Number: 1