MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 60/6 HCAP 10PK INT

Lot Number UNKNOWN

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) 2024, it was reported that patient's infusion set's tubing came apart as the patient lost three infusion sets over the last three months while sleeping.The site location was patient's abdomen, with the pump laying on the bed.Reportedly, the infusions were stored at room temperature.There was no stress or pull on the tubing and the pump was dropped with the set connected to patient's body.No further information available.

• Brand Name: MEDTRONIC EXTENDED
• Type of Device: UNO EWIS BLUE 60/6 HCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18847190
• MDR Text Key: 337518301
• Report Number: 8021545-2024-00123
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244022683
• UDI-Public: 05705244022683
• 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: 03/06/2024

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: UNKNOWN
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/06/2024
• Patient Sequence Number: 1