BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CHROMAGAR¿ CANDIDA MEDIUM; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL
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Model Number 254093 |
Device Problem
Contamination of Device Ingredient or Reagent (2901)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported when using the bd bbl¿ chromagar¿ candida medium , mold was observed.This event occurred ten times.The following information was provided by the initial reporter.The customer stated: "mold".
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Manufacturer Narrative
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H.6 investigation summary: during manufacturing of material 254093, media is formulated and sent through a high temperature short time sterilizer to remove bioburden.The petri dishes are subjected to uv radiation to decrease bioburden.The petri dishes are filled in a positive pressure hepa filtered environment.The filled plates are cooled and immediately wrapped into sleeves to decrease the introduction of microbes.Sleeves are then packaged into cartons and then transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the distributor.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media of 2 to 8 degrees c in a dark place.The batch history record review for batch 2097925 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include bioburden testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.All bioburden testing performed on this batch was satisfactory per bd internal procedures.Affected product does not have any sterility claims; the product is tested for bioburden prior to release to ensure that it conforms to product specifications.However, this does not ensure that the end-user will not receive a contaminated plate.The complaint history was reviewed, and one other complaint has been taken on batch 2097925 for contamination.Retention samples from batch 2097925 were not available for investigation.Two photos were received.Photo one shows a sleeve of plates with label lot 2097925 and a black area on the bottom plate inside the sleeve.Photo two shows a close up of photo one showing black area on the plate at the bottom of the sleeve.Chromagar candid(cut off area on label).Number 2097925 visible on label next to chinese writing.No return samples were received for investigation of this complaint.This complaint can be confirmed.The photos received verify the batch for this complaint.No complaint trends for this defect have been identified for this product, no actions are indicated at this time.Bd will continue to trend complaints for contamination.
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Event Description
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It was reported when using the bd bbl¿ chromagar¿ candida medium , mold was observed.This event occurred ten times.The following information was provided by the initial reporter.The customer stated: "mold.".
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Search Alerts/Recalls
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