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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. BD INFUSION SET IV INFUSION SET

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CAREFUSION 303, INC. BD INFUSION SET IV INFUSION SET Back to Search Results
Lot Number 20015485
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2020
Event Type  malfunction  
Event Description
Nurse of the patient reported multiple sets of iv tubing kinked at the top and not working.
 
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Brand NameBD INFUSION SET
Type of DeviceIV INFUSION SET
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key10133588
MDR Text Key194513454
Report Number10133588
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 05/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number20015485
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/27/2020
Event Location Hospital
Date Report to Manufacturer06/09/2020
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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