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.The patient's parents reported that their daughter faced a bent cannula which led to diabetic ketoacidosis.Reportedly, she slept overnight and woke up sick.Therefore, she was hospitalized.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: 18918825
• MDR Text Key: 337844636
• Report Number: 3003442380-2024-00191
• 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: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/12/2024
• Patient Sequence Number: 1