MAUDE Adverse Event Report: CONTACT¿DETACH; CONTACT DETACH G29 110/6

Lot Number 5160345

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient reported an issue with the infusion set a few weeks prior.Reportedly, the steel cannula broke off, while it was inside the patient's body.The blood glucose was 369 mg/dl and there were traces of ketones in the blood at the time of this event.The patient took medical consultation to get the cannula surgically removed from the body.The health care professional removed the cannula from the patient's body.No further information available.

• Brand Name: CONTACT¿DETACH
• Type of Device: CONTACT DETACH G29 110/6
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8513221
• MDR Text Key: 141906704
• Report Number: 3003442380-2019-01130
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244003330
• UDI-Public: 05705244003330
• Combination Product (y/n): N
• PMA/PMN Number: K041545
• 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: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 5160345
• Date Manufacturer Received: 05/31/2017
• Type of Device Usage: N
• Patient Sequence Number: 1