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

Lot Number	5160345
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Tissue Damage (2104)
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: CONTACT DETACH G29 110/6
• MDR Report Key: 8513221
• Report Number: 3003442380-2019-01130
• Device Sequence Number: 11202921
• Product Code: FPA
• UDI-Device Identifier: 05705244003330
• UDI-Public: 05705244003330
• Combination Product (Y/N): N
• PMA/510(K) Number: K041545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Lot Number: 5160345
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 04/15/2019
• Patient Sequence Number: 1