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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDIT II¿ SYRINGE WITH NEEDLE HYPODERMIC SYRINGE AND NEEDLE

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BECTON DICKINSON BD DISCARDIT II¿ SYRINGE WITH NEEDLE HYPODERMIC SYRINGE AND NEEDLE Back to Search Results
Catalog Number 300847
Device Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2018
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is (b)(4). This site is an oem manufacturing site. Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that the bd discardit ii¿ syringe with needle had difficult plunger movement. There was no report of exposure, injury, or medical intervention noted.
 
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Brand NameBD DISCARDIT II¿ SYRINGE WITH NEEDLE
Type of DeviceHYPODERMIC SYRINGE AND NEEDLE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7743846
MDR Text Key116051197
Report Number2243072-2018-01045
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number300847
Device Lot Number18B2311
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/02/2018 Patient Sequence Number: 1
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