MAUDE Adverse Event Report: T:90¿ INFUSION SET; INSET II 60/6 GREY

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.It was reported that the patient was hospitalized for diabetic ketoacidosis caused by a kinked cannula.The patient stayed in the hospital for three days and was released in a stable condition.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: T:90¿ INFUSION SET
• Common Device Name: INSET II 60/6 GREY
• MDR Report Key: 8538563
• Report Number: 3003442380-2019-01378
• Device Sequence Number: 19268629
• Product Code: FPA
• UDI-Device Identifier: 05705244004412
• UDI-Public: 05705244004412
• Combination Product (Y/N): N
• PMA/510(K) Number: K032854
• 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: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 04/23/2019
• Patient Sequence Number: 1