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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED QUICK SET INFUSION SET 23 INCH TUBING 9MM CANNULA SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED QUICK SET INFUSION SET 23 INCH TUBING 9MM CANNULA SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Kinked (1339)
Patient Problem No Information (3190)
Event Date 05/03/2018
Event Type  Injury  
Event Description
Pt was in dka d/t a kinked infusion set cannula. She uses quick set by medtronic and this is the 3rd admission for the same problem. "event abated after use stopped or dose reduced: yes. " route: subcutaneous. Therapy start date: (b)(6) 2018; therapy end date: (b)(6) 2018.
 
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Brand NameQUICK SET INFUSION SET 23 INCH TUBING 9MM CANNULA
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key7493896
MDR Text Key107767666
Report NumberMW5077031
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/07/2018 Patient Sequence Number: 1
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