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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 5ML EMERALD BNS

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BECTON DICKINSON, S.A. SYRINGE 5ML EMERALD BNS Back to Search Results
Catalog Number 303127
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. (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 different syringes were found with the syringes 5ml emerald bns during the packaging process. The customer reported 67733 occurrences of this event. The following information was provided by the initial reporter: i would like to inform you about new non-conformance that was detected at the beginning of the packaging process at our site. Inside the package with syringes p/n kz-03127-001 (bd p/n 303127), lot 71p19b0915 (bd batch 9029551) there were found 2 pieces of different syringe (pn unknown).
 
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Brand NameSYRINGE 5ML EMERALD BNS
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 Key8565160
MDR Text Key143810779
Report Number3002682307-2019-00277
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303127
Device Lot Number9029551
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 Received04/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2019
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: 04/30/2019 Patient Sequence Number: 1
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