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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD 20ML SYRINGE WITH LUER-LOK TIP PISTON, SYRINGE

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BECTON DICKINSON AND COMPANY BD 20ML SYRINGE WITH LUER-LOK TIP PISTON, SYRINGE Back to Search Results
Catalog Number REF 305617
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
An 80 bd 20ml syringes with luer-lok tip was found to be leaking from tip of the plunger after being filled with compounded sterile product. These 80 syringes had to be wasted. Fda safety report id# (b)(4).
 
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Brand NameBD 20ML SYRINGE WITH LUER-LOK TIP
Type of DevicePISTON, SYRINGE
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
franklin lakes NJ 07417
MDR Report Key10507201
MDR Text Key206326506
Report NumberMW5096468
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberREF 305617
Device Lot Number9184756
Was Device Available for Evaluation? Yes
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

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