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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD 10ML SYRINGE LUER-LOK TIP SYRINGE, PISTON

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BECTON, DICKINSON AND COMPANY BD 10ML SYRINGE LUER-LOK TIP SYRINGE, PISTON Back to Search Results
Lot Number 9294412
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 10/07/2020
Event Type  malfunction  
Event Description
Several bd 10ml syringes with luer-lok tips as well as several bd 20ml syringes with luer-lok tips were found to be leaking around the stopper of the plunger when filled with compounded sterile product. All of these had to be discarded.
 
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Brand NameBD 10ML SYRINGE LUER-LOK TIP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
MDR Report Key10683952
MDR Text Key211749791
Report NumberMW5097235
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 10/09/2020
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received10/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number9294412
Was Device Available for Evaluation? No
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?
Type of Device Usage

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