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 kingdom.On (b)(6) 2024, it was reported that the infusion set's tubing came apart at the belly button while the patient was in kitchen.The site location was patient's left side, and the pump was located on the same side.The infusion had been used for one hour.Reportedly, the infusions were stored in the kitchen.They were unsure of any stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information was 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: 18893114
• MDR Text Key: 337571847
• Report Number: 8021545-2024-00129
• 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: 03/13/2024

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: 03/07/2024
• Initial Date FDA Received: 03/13/2024
• Patient Sequence Number: 1