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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE SYRINGE, PISTON

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BECTON DICKINSON AND COMPANY BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE SYRINGE, PISTON Back to Search Results
Model Number NDC/HRI# 08290-8468-01 - 328468
Device Problem Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 07/03/2021
Event Type  malfunction  
Event Description
Needles of insulin syringes are defective and bend 50% of the time. The manufacturer bd is so cynical that did not test the bend needle syringe that i sent them. Fda safety report id# (b)(4).
 
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Brand NameBD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
MDR Report Key12301558
MDR Text Key266096124
Report NumberMW5103124
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNDC/HRI# 08290-8468-01 - 328468
Device Lot Number1046952 B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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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