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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PRECISIONGLIDE® SYRINGE NEEDLES

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BECTON DICKINSON IND. CIRURGICAS LTDA BD PRECISIONGLIDE® SYRINGE NEEDLES Back to Search Results
Catalog Number 300054
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. (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 bd precisionglide® syringe needles came in a box with mixed products. No report of serious injury or medical intervention.
 
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Brand NameBD PRECISIONGLIDE® SYRINGE NEEDLES
Type of DeviceNEEDLE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
Manufacturer (Section G)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7646548
MDR Text Key112871744
Report Number3003916417-2018-00154
Device Sequence Number0
Product Code FMF
Reporter Country CodeBR
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 07/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300054
Device Lot Number8046637
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 Received06/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2018
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: 06/28/2018 Patient Sequence Number: 1
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