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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, EXCLUDING MUELLER HINTON
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BECTON, DICKINSON & CO. (SPARKS) BD BBL GC II AGAR WITH ISOVITALEX ENRICHMENT; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON Back to Search Results
Catalog Number 254089
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter last name: (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¿ gc ii agar with isovitalex¿ enrichment atypical growth 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: "staphylococcal growth on this plate does not look good, or is not growing as it should.".
 
Event Description
It was reported that while using bd bbl¿ gc ii agar with isovitalex¿ enrichment atypical growth 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: "staphylococcal growth on this plate does not look good, or is not growing as it should.".
 
Manufacturer Narrative
H.6.Investigation: event description: it was reported that s.Epidermidis would show insufficient growth.Complaint history review: the complaints trends were reviewed for a period covering 12 months.There were no similar complaints received during that period on this product lot.Therefore, a trend could not be identified.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: picture sample was provided for evaluation.As per the provided pictures, white-greyish growth could be identified on the plate.An analysis of growth promotion for the media was performed on retention samples for batch 1096245.The performance tests on retention samples of the above mentioned batch resulted in excellent growth of the following strain: s.Epidermidis atcc 12228.After an incubation time of 1 day at 36°c ± 1°c in co2 atmosphere.Evaluation results: at this stage of our investigation, we have excluded any systemic failure in our production process.No deviation could be found during the qc performance test.During this test, the referenced s.Epidermidis atcc 12228 in the ifu were tested.Investigation conclusion: based on the evaluation of the report and based on the qc test results, the complaint was not confirmed.A corrective and preventive action will not be implemented as a trend could not be identified.A definite root cause could not be determined.We would suggest that you set aside, and not use, any prepared plated media that does not meet the appearance specification as it is described on the bd certificate of analysis.This is consistent with industry recommendations for inspection of culture media prior to use (e.G."good practices for pharmaceutical microbiology laboratories", who technical report series, no.961, 2011, annex 2; chapter (1117) "microbiology best laboratory practices" the united states pharmacopeia; and the difco & bbl manual).
 
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Brand Name
BD BBL GC II AGAR WITH ISOVITALEX ENRICHMENT
Type of Device
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
MDR Report Key12124406
MDR Text Key266033707
Report Number1119779-2021-01125
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
PMA/PMN Number
K945569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 07/23/2021
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 Expiration Date07/06/2021
Device Catalogue Number254089
Device Lot Number1096245
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/08/2021
Initial Date FDA Received07/06/2021
Supplement Dates Manufacturer Received07/23/2021
Supplement Dates FDA Received08/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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