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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD 3ML SYRINGE LUER-LOK TIP SYRINGE, PISTON

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BECTON DICKINSON AND COMPANY BD 3ML SYRINGE LUER-LOK TIP SYRINGE, PISTON Back to Search Results
Catalog Number 309657
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problem Exposure to Body Fluids (1745)
Event Date 08/23/2018
Event Type  malfunction  
Event Description
Bd 3ml syringe has a crack that resulted in a splash incident involving a staff when plunger was pushed during medication administration by medical assistant. No other syringes were found to be defective. Ref 309657, lot #8046992, exp: 02/28/2023, mfr: becton dickinson and company. Made in (b)(6). Dates of use: (b)(6) 2018.
 
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Brand NameBD 3ML SYRINGE LUER-LOK TIP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
MDR Report Key7832222
MDR Text Key118887593
Report NumberMW5079484
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 08/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number309657
Device Lot Number8046992
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

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