MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 60/6 HCAP 3-PK INT

Lot Number 5413271

Device Problem Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in canada.On (b)(6) 2024, the patient's mother reported that her son faced a bent cannula, and he experienced high blood glucose level of 24 mmol/l.Therefore, they tried to treat it by changing the entire infusion set.Moreover, the infusion set had been used for 4 days and the site location was patient's abdomen.Currently, his blood glucose level was 12 mmol/l.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 available.

• Brand Name: MEDTRONIC EXTENDED
• Type of Device: UNO EWIS BLUE 60/6 HCAP 3-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18577153
• MDR Text Key: 334755191
• Report Number: 8021545-2024-00103
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244023161
• UDI-Public: 05705244023161
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 5413271
• Date Manufacturer Received: 01/19/2024
• Patient Sequence Number: 1