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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ MUELLER HINTON II AGAR 150MM PLATE 24PK; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH
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BECTON DICKINSON GMBH BD BBL¿ MUELLER HINTON II AGAR 150MM PLATE 24PK; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH Back to Search Results
Catalog Number 254518
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2022
Event Type  malfunction  
Event Description
It was reported that bd bbl¿ mueller hinton ii agar 150mm plate 24pk was received with contamination on 1/3 of the customer's order.No patient impact reported.The following information was provided by the initial reporter: on the square mh we received a good part of them had condensation water and the agars are contaminated with multiple germs.This represents 1/3 of the order.
 
Manufacturer Narrative
Date of event: event occurrence date not provided.Used awareness date from global complaint.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 investigation summary: complaint history review: complaint history was reviewed and no similar complaint was identified for this batch number.Batch history record (bhr) review: no bhr could be performed since no batch number was communicated.Sample analysis: as the batch number was not communicated, retain samples of other batches were reviewed and the issue could not be observed.Return samples were not provided however pictures illustrating the contamination on plates as well as condensation were shared but the pictures are not exhibiting the affected batch number.Evaluation results: after investigations, no deviation could be detected in our validated manufacturing process.Since no batch number was communicated, retain samples from other batches were reviewed and the complained issue couldn't be observed.Therefore no further investigations will be performed this time.Investigation conclusion: based on the above mentioned evaluation, the complaint cannot be confirmed.However will continue to monitor incoming complaints for similar defect types h3 other text : see h.10.
 
Event Description
It was reported that bd bbl¿ mueller hinton ii agar 150mm plate 24pk was received with contamination on 1/3 of the customer's order.No patient impact reported.The following information was provided by the initial reporter: on the square mh we received a good part of them had condensation water and the agars are contaminated with multiple germs.This represents 1/3 of the order.
 
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Brand Name
BD BBL¿ MUELLER HINTON II AGAR 150MM PLATE 24PK
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 Key15442517
MDR Text Key303923542
Report Number9680577-2022-00098
Device Sequence Number1
Product Code JTZ
Combination Product (y/n)N
Reporter Country CodeFR
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 09/26/2022
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 Catalogue Number254518
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/30/2022
Initial Date FDA Received09/16/2022
Supplement Dates Manufacturer Received09/26/2022
Supplement Dates FDA Received10/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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