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 italy.It was reported that on (b)(6) 2023, the patient faced a bent cannula which led to high blood glucose level, vomiting, diarrhea and was out of balance.Therefore, on the same day ((b)(6) 2023), in the afternoon, the patient went to the emergency room in an ambulance due to high blood glucose level.Moreover, she went through a computed tomography scan (ct scan) and noticed that her cannula was bent.Her highest blood glucose level was 750 mg/dl and had traces of ketone level.While in the emergency room, she was tested positive for corona virus disease (covid).During her stay in the emergency room, the patient received fluids of saline (unknown), insulin vials and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue as her blood glucose level fell down to 171 mg/dl.On (b)(6) 2023, the patient was released from the hospital with no permanent damage.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: INFUSION DEVICES - UNKNOWN
• Type of Device: INFUSION DEVICES - UNKNOWN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18532564
• MDR Text Key: 333088362
• Report Number: 3003442380-2024-00120
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/09/2024
• Patient Sequence Number: 1