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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT II SYRINGE W/O NEEDLE

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BECTON DICKINSON, S.A. BD DISCARDIT II SYRINGE W/O NEEDLE Back to Search Results
Catalog Number 300296
Device Problems Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Device Markings/Labelling Problem (2911)
Patient Problem No Information (3190)
Event Date 01/16/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported with the use of the bd discardit ii syringe w/o needle there was an issue with leakage from the back of the body, cannula not sitting firmly on cone, scaling difficult to see and fingertip is broken off on syringe.
 
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Brand NameBD DISCARDIT II SYRINGE W/O NEEDLE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8293973
MDR Text Key134900400
Report Number3002682307-2019-00115
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeGM
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300296
Device Lot Number1806173
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2018
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: 01/31/2019 Patient Sequence Number: 1
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