MAUDE Adverse Event Report: INFUSION DEVICES - UNKNOWN

Lot Number UNKNOWN

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2018, the patient reported that he usually had a bent cannula so had to change often almost every day and this had occurred for a few months.The infuion as last changed on (b)(6) 2018.However, on (b)(6) 2018 midnight, he was admitted to the hospital with blood glucose level of 925 mg/dl and diabetic ketoacidosis due to a bent cannula, where he was administered an insulin drip intravenously.Currently, his blood glucose level was 200 mg/dl.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: INFUSION DEVICES - UNKNOWN
• Type of Device: INFUSION DEVICES - UNKNOWN
• MDR Report Key: 12409153
• MDR Text Key: 269422951
• Report Number: 3003442380-2021-00425
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/20/2021
• Type of Device Usage: N
• Patient Sequence Number: 1