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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; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
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BECTON DICKINSON GMBH BD BBL¿ MUELLER HINTON II AGAR; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST Back to Search Results
Catalog Number 254081
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2021
Event Type  malfunction  
Event Description
It was reported that while using bd bbl¿ mueller hinton ii agar 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: "the plates arrived with mold on the agar.Upon arrival the plates had mold growth on the agar".
 
Manufacturer Narrative
(b)(6).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 was reported that while using bd bbl¿ mueller hinton ii agar 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: "the plates arrived with mold on the agar.Upon arrival the plates had mold growth on the agar".
 
Manufacturer Narrative
Investigation summary: it was reported that plates would be contaminated.Complaint history review: the complaints trends were reviewed and similar complaints were found to be reported for this lot number.Batch history record (bhr) review: the batch history review did not indicate any discrepancies.All release testing was satisfactory and no deviations were observed.Sample analysis: a visual inspection was performed on retention samples and incubated for one week.As a result of this analysis no contamination was observed.Picture sample documenting the reported contamination was provided.As per the pictures contaminated plates were shown.Evaluation results: at this stage of our investigation, we have excluded any systemic failure in our manufacturing process.This product does not have an sal (sterility assurance level) claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.Please note that the valid standard for these products is din en 12322 "in vitro diagnostic medical devices - culture media for microbiology".According to this standard the contamination rate for each product lot must not exceed (b)(4).Based upon our continuous monitoring, we derive a contamination rate that falls below this specified value.According to our high quality standard, we only release product batches to the market with an aql (acceptable quality level) = 1.5.Although this contamination level is very low, we cannot completely exclude that a customer may receive contaminated plates.As similar complaints were reported for this issue, internal investigations were performed.Investigation conclusion: based on the evaluation and the provided pictures, the complaint was confirmed for contamination.
 
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Brand Name
BD BBL¿ MUELLER HINTON II AGAR
Type of Device
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12434322
MDR Text Key283314309
Report Number9680577-2021-00055
Device Sequence Number1
Product Code JTZ
Combination Product (y/n)N
Reporter Country CodeAU
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 12/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/12/2021
Device Catalogue Number254081
Device Lot Number1173788
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2021
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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