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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY/CAREFUSION 303, INC. BD 3ML LEUR-LOK TIP SYRINGE SYRINGE, PISTON

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BECTON, DICKINSON AND COMPANY/CAREFUSION 303, INC. BD 3ML LEUR-LOK TIP SYRINGE SYRINGE, PISTON Back to Search Results
Catalog Number REF309657
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
Bd 3ml syringe molding defect resulting in leaks when using the bd 3ml syringe infusions in the neonatal icu; problem occurred (b)(6) through (b)(6) 2020; multiple product lots involved. Fda safety report id#: (b)(4).
 
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Brand NameBD 3ML LEUR-LOK TIP SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY/CAREFUSION 303, INC.
MDR Report Key9982636
MDR Text Key188691970
Report NumberMW5094202
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/16/2020
6 Devices were Involved in the Event: 1   2   3   4   5   6  
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberREF309657
Device Lot Number9048592
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/16/2020
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/20/2020 Patient Sequence Number: 1
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