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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 01/11/2023
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 mold found in media before usage.The following information was provided by the initial reporter: mold was found in the media before usage.
 
Manufacturer Narrative
H.6 investigation summary: 251267.#2327899.Bd had not received samples, but one (1) photo was provided for investigation.The photo was reviewed and the indicated failure mode for contamination was observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode contamination.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that plate chocolate ii agar 100 ea mold found in media before usage.The following information was provided by the initial reporter: mold was found in the media before usage.
 
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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 Key16221936
MDR Text Key308084757
Report Number1119779-2023-00048
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 01/24/2023
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 Expiration Date03/21/2023
Device Catalogue Number251267
Device Lot Number2327899
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/12/2023
Initial Date FDA Received01/23/2023
Supplement Dates Manufacturer Received01/24/2023
Supplement Dates FDA Received01/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/23/2022
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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