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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT

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TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT Back to Search Results
Model Number 1002833
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Hyperglycemia (1905)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. It was reported that on (b)(6) 2021 and once about two weeks ago, the patient's infusion set's tubing detached/broken at the site connector. Therefore, her blood glucose level was between the range of 400-500 mg/dl, however there were few times she went above 500 mg/dl. Her highest blood glucose level was 582 mg/dl, which they tried to treat with correction bolus via pump and changed the infusion set. Moreover, they replaced the infusion set and insulin was resumed successfully. No further information available.
 
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Brand NameTRUSTEEL
Type of DeviceUNO CONTACT DETACH G29 60/6TCAP 10PK INT
MDR Report Key12597451
MDR Text Key275388006
Report Number3003442380-2021-00542
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K041545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 10/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1002833
Device Lot Number5345320
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2021
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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