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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH
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BECTON, DICKINSON & CO. (SPARKS) BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH Back to Search Results
Catalog Number 251176
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2022
Event Type  malfunction  
Event Description
It was reported while testing with bbl - mueller hinton agar with 5% sheep blood biological contamination is found.Confirmatory testing was performed using (tests).There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: according to the customer's report, the top plate was found to be contaminated.
 
Manufacturer Narrative
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 while testing with bbl - mueller hinton agar with 5% sheep blood biological contamination is found.Confirmatory testing was performed using (tests).There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: according to the customer's report, the top plate was found to be contaminated.
 
Manufacturer Narrative
H6: investigation summary the complaint was confirmed as the reported defect on a picture.The issue was contamination.Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.See h10.
 
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Brand Name
BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
Type of Device
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH
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 Key13699126
MDR Text Key287579535
Report Number1119779-2022-00397
Device Sequence Number1
Product Code JTZ
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 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/23/2022
Device Catalogue Number251176
Device Lot Number1328282
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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