MAUDE Adverse Event Report: MIO¿; INSET II 80/6 PCC BLUE

Lot Number	UNKNOWN
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient's father reported, his son began throwing up and was advised to go the hospital.Due to high glucose the infusion set was pulled out and cannula was found to be bent and site location was upper hip.The patient was diagnosed with diabetic ketoacidosis.The patient was admitted to the hospital for four days.The patient received intravenous insulin drip as a corrective treatment in the hospital.Reportedly, infusion was in use for only one day and the patient had four sets which were bent.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.
Event or Problem Description
On 16-oct-2019: follow up information was submitted because result of complaint investigation of the returned used device (1 set) showed that the soft cannula was found to be bent (at the tip) and the pcc connector needle was clogged (by insulin).Based on the result: method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.The patient's father reported, his son began throwing up and was advised to go the hospital.Due to high glucose the infusion set was pulled out and cannula was found to be bent and site location was upper hip.The patient was diagnosed with diabetic ketoacidosis.The patient was admitted to the hospital for four days.The patient received intravenous insulin drip as a corrective treatment in the hospital.Reportedly, infusion was in use for only one day and the patient had four sets which were bent.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 available.

• Brand Name: MIO¿
• Common Device Name: INSET II 80/6 PCC BLUE
• MDR Report Key: 8207612
• Report Number: 3003442380-2018-00151
• Device Sequence Number: 16195999
• Product Code: FPA
• UDI-Device Identifier: 05705244007734
• UDI-Public: 05705244007734
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1