MAUDE Adverse Event Report: QUICK-SET®; QUICK-SET 110/6

Lot Number	5187515
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 faced bent cannula issue.His blood glucose level was 470 mg/dl and he suffered from vomiting and dehydration.The emergency medical service was called, and the patient was admitted to the hospital.He was given insulin drip as corrective treatment.The patient was hospitalized for two and a half days.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: QUICK-SET®
• Common Device Name: QUICK-SET 110/6
• MDR Report Key: 8548023
• Report Number: 3003442380-2019-01303
• Device Sequence Number: 400267
• Product Code: FPA
• UDI-Device Identifier: 05705244006638
• UDI-Public: 05705244006638
• Combination Product (Y/N): N
• PMA/510(K) Number: K991759
• 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: 5187515
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/25/2019
• Patient Sequence Number: 1