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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST

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BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST Back to Search Results
Model Number 221240
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2022
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 has been reported that the bd bbl¿ gc ii agar with isovitalex¿ enrichment has been found experiencing two occurrences of containing contamination. The following has been provided by the initial reporter: the customer is reporting contamination on their plates.
 
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Brand NameBD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT
Type of DeviceCULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
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 Key13425846
MDR Text Key288595579
Report Number1119779-2022-00185
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K945569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/16/2022
Device Model Number221240
Device Catalogue Number221240
Device Lot Number1288048
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2021
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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