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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE

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BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE Back to Search Results
Catalog Number 300928
Device Problem Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2018
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 that a bd discardit¿ ii syringe contained air bubbles. No report of serious injury or medical intervention.
 
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Brand NameBD DISCARDIT¿ II SYRINGE
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
8015652845
MDR Report Key7749611
MDR Text Key116389032
Report Number3002682307-2018-00192
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup
Report Date 08/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300928
Device Lot Number1802149
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 Received07/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2018
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: 08/03/2018 Patient Sequence Number: 1
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