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 united states.It was reported that a (b)(6) female child patient was admitted in the hospital.The nurse looked at the pump and noticed that her settings in the pump were completely different.Almost every bolus was an override bolus for a significant amount more insulin that the pump calculated.Further, the patient was in the clinic for follow up and noted to have ketones and high blood glucose level.The nurse told her to assume it as a bad site and they took it off and noticed that the cannula was indeed kinked.The patient said she was not told anything about the fact that it could do that.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
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14600507
• MDR Text Key: 293334292
• Report Number: 3003442380-2022-00733
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K032854
• 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: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/26/2022
• Patient Sequence Number: 1