MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 60/9 HCAP 3-PK INT

Lot Number UNKNOWN

Device Problem Material Twisted/Bent (2981)

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, the patient's father reported that his child faced a kinked cannula leading to high blood glucose level.The site location was patient's leg, and the infusion set was used for one day.Reportedly, the patient lost four infusion set as they were repeatedly getting insulin flow block alarm which resolved by changing the infusion set.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information was available.

• Brand Name: MEDTRONIC EXTENDED
• Type of Device: UNO EWIS BLUE 60/9 HCAP 3-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18949968
• MDR Text Key: 339323613
• Report Number: 8021545-2024-00132
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244023284
• UDI-Public: 05705244023284
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/14/2024
• Patient Sequence Number: 1