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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 12/22/2022
Event Type  malfunction  
Manufacturer Narrative
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 plate chocolate ii agar 100 ea growth is insufficient in some plates and additional cultivation is needed.No injuries were reported.The following information was provided by the initial reporter: growth is insufficient in those plates and additional cultivation is needed.
 
Manufacturer Narrative
H.6 investigation summary: 51267.#2305035.We couldn't confirm this issue as a report from returned sample.No issue in returned sample.We observed returned sample, then retested performance testing.As a result, all qc strains were sufficient growth.Complaint history was reviewed, and no other complaint has been taken on this lot.At this time.Dhr did not indicate any discrepancies.All release testing was satisfactory and no deviations were observed.A visual inspection was performed on 20 retention samples of this lot.As a result,no defect was observed.The root cause for this could not be determined.We will continue to monitor this lot.
 
Event Description
It was reported that plate chocolate ii agar 100 ea growth is insufficient in some plates and additional cultivation is needed.No injuries were reported.The following information was provided by the initial reporter: growth is insufficient in those plates and additional cultivation is needed.
 
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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 Key16078132
MDR Text Key306834864
Report Number1119779-2022-01562
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 02/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/06/2023
Device Catalogue Number251267
Device Lot Number2284925
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2022
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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