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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD SYRINGE SYRINGE, PISTON

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BD SYRINGE SYRINGE, PISTON Back to Search Results
Model Number 303310
Device Problems Difficult to Advance (2920); Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2020
Event Type  malfunction  
Event Description
Db 20 ml syringe luer-lok tip packaging tore to compromise sterility of syringe. After opening syringe, the plunger does not properly advance and pull back when drawing up liquids. Fda safety report id# (b)(4).
 
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Brand NameSYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BD
franklin lakes NJ 07417
MDR Report Key10319623
MDR Text Key200599995
Report NumberMW5095687
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
Type of Report Initial
Report Date 07/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number303310
Device Lot Number9339646
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? No
Type of Device Usage

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