MAUDE Adverse Event Report: MIO; INSET II 80/9 PCC GREY

Model Number	MMT-975
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.It was reported that on (b)(6) 2018, the patient was admitted in the intensive care unit with blood glucose level of 1200 mg/dl because of bent cannula.During hospitalization, the patient was treated with insulin drip as corrective treatment.On (b)(6) 2018, the patient was released from the hospital.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.
Event or Problem Description
On (b)(6) 2020: follow up information was submitted to update the lot number, expiry date and because results of complaint investigation of the returned 3 used cannulas were received.In the visual inspection, it was found that the soft cannula was kinked (at the middle and tip) but the flow test results were in accordance with specifications.In the one used set, during the visual inspection, it was found that the soft cannula was kinked (at the tip) but the flow test results were in accordance with specifications.Moreover, in one another used set, during the visual inspection, it was found the soft cannula was kinked (at the tip and middle) and in the flow test found 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 it was reported that on (b)(6) 2018, the patient was admitted in the intensive care unit with blood glucose level of 1200 mg/dl because of a bent cannula.During hospitalization, the patient was treated with insulin drip as corrective treatment.On (b)(6) 2018,the patient was released from the hospital.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 80/9 PCC GREY
• MDR Report Key: 9773648
• Report Number: 3003442380-2020-00191
• Device Sequence Number: 2330857
• Product Code: FPA
• UDI-Device Identifier: 05705244007833
• UDI-Public: 05705244007833
• 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 Expiration Date: 01/01/2022
• Device Model Number: MMT-975
• Device Lot Number: 5267094
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 05/14/2020
• Patient Sequence Number: 1