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U.S. Department of Health and Human Services

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

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BECTON, DICKINSON AND COMPANY 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 02/28/2020
Event Type  malfunction  
Event Description
Nyicu (nursery intensive care unit) rn noted leaking at buff cap where 3 ml syringe connected [to an infusion pump] for infusion on a preemie (premature) infant. Antibiotic was contained inside a bd 3 ml syringe. This report is being made for tracking purposes due to this continuing issue. We do not have the serial or model number as the syringes are previously filled in pharmacy. Company is aware of this issue.
 
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Brand NameBECTON, DICKINSON AND COMPANY
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key9947884
MDR Text Key187203850
Report Number9947884
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
Report Date 03/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2020
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 Manufacturer04/10/2020
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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