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

Lot Number 5396881

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 the infusion set's tubing got disconnected from site (tubing disconnected from the blue crip that goes into the infusion set) while the patient was sitting in a chair.The site location was left rear high hip, and the pump was in front of bra area.The infusion had been used for three days.Reportedly, the infusions were stored inside at home top shelf in kitchen.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.According to the complaint investigation performed on the returned used device (1 set), it was found that the tubing was detached from the tubing connector.No further information was 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: 18989661
• MDR Text Key: 338747204
• Report Number: 8021545-2024-00134
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244022836
• UDI-Public: 05705244022836
• Combination Product (y/n): N
• 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: 03/28/2024

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 Expiration Date: 06/01/2024
• Device Lot Number: 5396881
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 03/27/2024
• Patient Sequence Number: 1