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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD INSULIN SYRINGE SYRINGE, PISTON

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BD BD INSULIN SYRINGE SYRINGE, PISTON Back to Search Results
Model Number 08290-3249-11
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Bd insulin syringes fail to draw more than 0. 025 ml of any fluid when used appropriately. Failure repeats in multiple lots and has been noted by multiple providers and patients, as well.
 
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Brand NameBD INSULIN SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BD
one becton drive
franklin lakes NJ 07417
MDR Report Key7369249
MDR Text Key103554957
Report NumberMW5076084
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
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received03/23/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number08290-3249-11
Device Lot NumberNUMEROUS
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?
Type of Device Usage

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