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U.S. Department of Health and Human Services

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

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SURE-T PARADIGM UNO CONTACT DETACH G29 60/6 PCC MIMX Back to Search Results
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.
 
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Brand NameSURE-T PARADIGM
Type of DeviceUNO CONTACT DETACH G29 60/6 PCC MIMX
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key11869252
MDR Text Key252318508
Report Number3003442380-2021-00258
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-864
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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