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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD SET, ADMINISTRATION, INTRAVASCULAR

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BD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Collapse (1099); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2020
Event Type  malfunction  
Event Description
Patient received gemcitabine today. Bag was collapsed and there was still chemo in line and drip chamber. Pump was erroring that the chamber was empty.
 
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Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BD
one becton drive
franklin lakes NJ 07417
MDR Report Key9915852
MDR Text Key186135616
Report Number9915852
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/06/2020,01/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/06/2020
Event Location Outpatient Treatment Facility
Date Report to Manufacturer04/02/2020
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? No
Type of Device Usage

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