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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
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
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
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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