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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON & CO LEUR - LOK 3CC MIS 23GX1 SYRINGE, PISTON

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BECTON DICKINSON & CO LEUR - LOK 3CC MIS 23GX1 SYRINGE, PISTON Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2019
Event Type  malfunction  
Event Description
Sent syringe 23g 1. 5 in 3ml when md wanted syr 1ml (without needle).
 
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Brand NameLEUR - LOK 3CC MIS 23GX1
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON & CO
MDR Report Key8366729
MDR Text Key137249848
Report NumberMW5084321
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 02/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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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