MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 60/6 PCC

Lot Number UNKNOWN

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

(b)(4).Event occurred in the united states.The patient was hospitalized for diabetes ketoacidosis and reported cannula was bent.The patient's mother took the patient to the emergency room for vomiting due to high blood glucose level of 643 mg/dl.Reportedly, the patient feeling sick as well.The patient received intravenous fluids and insulin drop as corrective treatment.Currently, the patient's blood glucose level was 106 mg/dl.The patient was in intensive care unit for 5 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® PARADIGM®
• Type of Device: QUICK-SET 60/6 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8195384
• MDR Text Key: 131370187
• Report Number: 3003442380-2018-00167
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006331
• UDI-Public: 05705244006331
• Combination Product (y/n): N
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/30/2018
• Type of Device Usage: N
• Patient Sequence Number: 1