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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON & CO. 3 ML SYRINGE SYRINGE, PISTON

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BECTON DICKINSON & CO. 3 ML SYRINGE SYRINGE, PISTON Back to Search Results
Lot Number 0155075
Device Problem Crack (1135)
Patient Problem Insufficient Information (4580)
Event Type  No Answer Provided  
Event Description
Syringe has cracks in it. Fda safety report id # (b)(4).
 
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Brand Name3 ML SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON & CO.
MDR Report Key10770400
MDR Text Key214395802
Report NumberMW5097597
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 10/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot Number0155075
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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