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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL
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BECTON DICKINSON GMBH BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL Back to Search Results
Catalog Number 257481
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2021
Event Type  malfunction  
Event Description
It was reported that 13 plates of bd bbl¿ chromagar¿ orientation agar were contaminated.The following information was provided by the initial reporter: contaminated plates with moulds growing.Contaminated plates detected when boxes of plates were opened.Out of 20 boxes received, 13 boxes showed contamination.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H.6.Investigation: this statement is to summarize findings on the recent complaint 3885767 against bbl¿ chromagar¿ orientation medium, catalog number 257481, lot number 1223071.Event description: it was reported that contamination was detected in 13 boxes with plates.Complaint history review: complaint history was reviewed and no similar complaints were recorded for the respective batch.However, since this product is filled aseptically with an aql for sterility of 1.5 rare contamination events are to be expected.Therefore a trend could not be identified.Batch history record (bhr) review: the bhr was reviewed.No deviation from the validated processes and parameters were registered.Sample analysis: the retain samples were reviewed and no deviation could be detected.Picture sample was provided showing contaminated plates.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 4.9%.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.Investigation conclusion: based on the evaluation and and provided pictures, the complaint was confirmed for contamination.We would suggest to 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).H3 other text : see h.10.
 
Event Description
It was reported that 13 plates of bd bbl¿ chromagar¿ orientation agar were contaminated.The following information was provided by the initial reporter: contaminated plates with moulds growing.Contaminated plates detected when boxes of plates were opened.Out of 20 boxes received, 13 boxes showed contamination.
 
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Brand Name
BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR
Type of Device
CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL
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 Key12883667
MDR Text Key285956919
Report Number9680577-2021-00087
Device Sequence Number1
Product Code JSH
Combination Product (y/n)N
Reporter Country CodeLG
PMA/PMN Number
EXEMPT
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 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/05/2021
Device Catalogue Number257481
Device Lot Number1223071
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2021
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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