MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 60/6 HCAP 1-PK INT

Lot Number 5363954

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 (b)(6).On (b)(6) 2022, it was reported that the patient's infusion set's tubing detached at the connection site of tubing and site.The infusion set had not been used.Reportedly, there was no stress or pull on the tubing and the pump was not 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 1-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14039842
• MDR Text Key: 288875769
• Report Number: 8021545-2022-00130
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244022928
• UDI-Public: 05705244022928
• 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: 04/07/2022

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: 5363954
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/07/2022
• Patient Sequence Number: 1