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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PLATE MUELLER HINTON II AGAR 20 EA; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
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BECTON, DICKINSON & CO. (SPARKS) PLATE MUELLER HINTON II AGAR 20 EA; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST Back to Search Results
Catalog Number 251177
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2022
Event Type  malfunction  
Event Description
It was reported that while using 2 plate mueller hinton ii agar 20 ea contamination was observed by the laboratory personnel.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: "this is a report about media contamination.".
 
Manufacturer Narrative
In this mdr, bd ds headquarters in (b)(6) has been listed as fukushima is an oem manufacturing site.There is no 510(k) for this device as it is manufactured outside the us and not sold in the us but is considered to be substantially similar to the legally u.S.Marketed device bd bbl¿ mueller hinton ii agar catalog number 211438 which is a preamendment device.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6 investigation summary: we confirmed contamination from returned sample.Device history record/ batch history record review was acceptable no issue in retention, although it was already expired when we received returned sample.Root cause was undetermined.We will continue to monitor this issue.
 
Event Description
It was reported that while using 2 plate mueller hinton ii agar 20 ea contamination was observed by the laboratory personnel.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: "this is a report about media contamination.".
 
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Brand Name
PLATE MUELLER HINTON II AGAR 20 EA
Type of Device
CULTURE 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 Key15089093
MDR Text Key304624777
Report Number1119779-2022-01018
Device Sequence Number1
Product Code JTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PREAMENDMENT
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 10/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/25/2022
Device Catalogue Number251177
Device Lot Number2088793
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2022
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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