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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 3ML LS EMERALD

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BECTON DICKINSON SYRINGE 3ML LS EMERALD Back to Search Results
Catalog Number 302986
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. The manufacturing location for this product is (b)(4) this site is not registered with the fda. Therefore, bd corporate headquarters in (b)(4) has been listed in and the (b)(4) fda registration number has been used for the manufacture report number. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that syringe 3ml ls emerald blister pack was discolored. This occurred on 220 occasions. The following information was provided by the initial reporter: sterile 3ml syringe with a plastic protective wrapping that is not completely transparent. Presence of stains on plastic packaging of all syringes.
 
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Brand NameSYRINGE 3ML LS EMERALD
Type of DeviceSYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11673685
MDR Text Key253164648
Report Number2243072-2021-01155
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
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 05/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302986
Device Lot Number0317490
Was Device Available for Evaluation? No
Date Returned to Manufacturer04/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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