MAUDE Adverse Event Report: MIO¿; INSET II 46/6 PCC PINK

Lot Number	5260656
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 (b)(6).The mother of the patient reported that her daughter experienced vomiting, abdominal pain and difficulty in breathing.Further, she had high blood glucose levels and diabetic ketoacidosis for which she was brought to the hospital.Subsequently, on (b)(6) 2019, she was admitted to the hospital, with blood glucose level of approximately 33.3 mmol/l and positive results as 6.8 mmol/l in the ketones test due to a bent cannula which was noticed upon removal.During hospitalization, she received syringes and drug name unknown (intravenously) for hydration as a corrective treatment.At the hospital they treated her and put her back on the pump and she got a bent cannula again.Moreover, she was on an injection and they will switch her to another pump as per the health care professional's recommendation.The infusion was last changed in the morning of the same day and she had two of the sites which were bent.On (b)(6) 2019, she 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 46/6 PCC PINK
• MDR Report Key: 9393541
• Report Number: 3003442380-2019-01949
• Device Sequence Number: 14118152
• Product Code: FPA
• UDI-Device Identifier: 05705244007390
• UDI-Public: 05705244007390
• 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

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: 02/01/2022
• Device Lot Number: 5260656
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/02/2019
• Patient Sequence Number: 1