MAUDE Adverse Event Report: SURE-T PARADIGM; UNO CONTACT DETACH G29 60/6 PCC MIMX

Model Number MMT-864

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient experienced high blood glucose level (above 400 mg/dl) due to a bent cannula.Therefore, he was hospitalized due to high blood glucose level for over 40 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: SURE-T PARADIGM
• Type of Device: UNO CONTACT DETACH G29 60/6 PCC MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 11869252
• MDR Text Key: 252318508
• Report Number: 3003442380-2021-00258
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244005778
• UDI-Public: 05705244005778
• Combination Product (y/n): Y
• 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: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MMT-864
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/10/2021
• Type of Device Usage: N
• Patient Sequence Number: 1