MAUDE Adverse Event Report: INFUSION DEVICES - UNKNOWN

Lot Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hyperglycemia (1905); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021, the patient reported that cannula broke inside his body and this issue occurred twice, as for the first incident he could not remember the date, but the second incident happened last weekend.Therefore, on (b)(6) 2021, at 12:00 pm, the patient was admitted to the hospital with blood glucose level of 336 mg/dl.They need to surgically investigate the cannula as they could not find it in the ultrasound.Subsequently, they removed the cannula from his body.Reportedly, the cannula was inserted in his abdomen and the cannula or needle had been used for two days.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: 11336313
• MDR Text Key: 232183372
• Report Number: 3003442380-2021-00152
• 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: 02/17/2021
• 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: 02/09/2021
• Type of Device Usage: N
• Patient Sequence Number: 1