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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PUMP TUBING SET, ADMINISTRATION, INTRAVASCULAR

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PUMP TUBING SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)
Patient Problem Hyperglycemia (1905)
Event Date 08/06/2021
Event Type  Injury  
Event Description
Patient had to go to the hospital, as her insulin pump tubing was kinked or clogged. Her glucose was very elevated as a result.
 
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Brand NamePUMP TUBING
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12313733
MDR Text Key266502690
Report NumberMW5103219
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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: 08/11/2021 Patient Sequence Number: 1
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