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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD PLATE MUELLER HINTON II AGAR 150MM 20; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH
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BECTON DICKINSON GMBH BD PLATE MUELLER HINTON II AGAR 150MM 20; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH Back to Search Results
Catalog Number 254062
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2022
Event Type  malfunction  
Event Description
It was reported while testing with bd plate mueller hinton ii agar 150mm 20 biological contamination was observed on the media.There was no report of patient impact.The following information was provided by the initial reporter: the plates were received crashed and with growing in the media.Before the use the customer saw that the material was in not optimal stage.
 
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
H.6: device evaluation: it was reported while testing with bd plate mueller hinton ii agar 150mm 20 biological contamination was observed on the media.There was no report of patient impact.The following information was provided by the initial reporter: the plates were received crashed and with growing in the media.Before the use the customer saw that the material was in not optimal stage.
 
Event Description
It was reported while testing with bd plate mueller hinton ii agar 150mm 20 biological contamination was observed on the media.There was no report of patient impact.The following information was provided by the initial reporter: the plates were received crashed and with growing in the media.Before the use the customer saw that the material was in not optimal stage.
 
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Brand Name
BD PLATE MUELLER HINTON II AGAR 150MM 20
Type of Device
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH
Manufacturer (Section D)
BECTON DICKINSON GMBH
8-12 tullastrasse
heidelberg 69126
GM  69126
Manufacturer (Section G)
BECTON DICKINSON GMBH
8-12 tullastrasse
heidelberg 69126
GM   69126
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14251280
MDR Text Key290458678
Report Number9680577-2022-00063
Device Sequence Number1
Product Code JTZ
Combination Product (y/n)N
Reporter Country CodeSP
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 07/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/15/2022
Device Catalogue Number254062
Device Lot Number2014166
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2022
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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