MAUDE Adverse Event Report: INFUSION DEVICES - UNKOWN

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 (b)(6).It was reported that on (b)(6) 2019, a young boy experienced severe hyperglycemia, which the parents of the patient tried to treat by giving a bolus using the pump, but the blood sugar values continued to rise.Reportedly, on the same day ((b)(6) 2019) in the evening at 7:30 pm, the patient was taken to the hospital with high blood glucose level and ketone level 2.5 mmol/l, where they discovered that high blood glucose level was due to a kinked/ bent cannula.On (b)(6) 2019, he was released from the hospital and was home again at 2:00 am.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 - UNKOWN
• Type of Device: INFUSION DEVICES - UNKOWN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 9514493
• MDR Text Key: 182595786
• Report Number: 3003442380-2019-01988
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/24/2019
• Type of Device Usage: N
• Patient Sequence Number: 1