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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PLATE CHOCOLATE II AGAR 100 EA; CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
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BECTON, DICKINSON & CO. (SPARKS) PLATE CHOCOLATE II AGAR 100 EA; CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA Back to Search Results
Catalog Number 251267
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2022
Event Type  malfunction  
Event Description
It was reported that plate chocolate ii agar 100 ea insufficient growth occurred.The following information was provided by the initial reporter: the customer found that the media in the top dish of a sleeve was thin.Bacterial growth in this affected plate was insufficient.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
 
Event Description
It was reported that plate chocolate ii agar 100 ea insufficient growth occurred.The following information was provided by the initial reporter: the customer found that the media in the top dish of a sleeve was thin.Bacterial growth in this affected plate was insufficient.
 
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Brand Name
PLATE CHOCOLATE II AGAR 100 EA
Type of Device
CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer (Section G)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15936206
MDR Text Key306269488
Report Number1119779-2022-01470
Device Sequence Number1
Product Code JTY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number251267
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/01/2022
Initial Date FDA Received12/07/2022
Supplement Dates Manufacturer Received01/25/2023
Supplement Dates FDA Received01/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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