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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE, PISTON

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BECTON DICKINSON AND COMPANY SYRINGE, PISTON Back to Search Results
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2020
Event Type  malfunction  
Event Description
Report being submitted for tracking purposes as we do not have model, lot or serial numbers available. Nyicu (nursery intensive care unit) rn reported that new 3ml (bd) dopamine syringe that was started by day shift late in shift was found (by day shift rn while reporting off) to be leaking. The underside of the infusion pump was wet. New syringe was scanned and the dopamine transferred to a 5ml syringe (as this was 2nd 3ml dopamine syringe found to leak on this date). Had to transfer back to a 3ml syringe later in night when dosage decreased to under. 1ml/hr. Syringe/buff cap saved in bag and given to manager.
 
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Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
one becton drive
franklin lakes NJ 07417
MDR Report Key9943935
MDR Text Key187081882
Report Number9943935
Device Sequence Number1
Product Code FMF
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,Followup
Report Date 03/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/24/2020
Event Location Hospital
Date Report to Manufacturer04/09/2020
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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