Catalog Number 221261 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2021 |
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 that a bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) plate was contaminated.The following information was provided by the initial reporter: "quantity of product received in shipment? 23.Quantity of product affected? (please clarify the number of tubes) 1 plate.Was the contamination noticed before or after inoculation? before.Customer problem: customer reported a blood agar quantity received and quantity affected: 23 received and 1 plate contaminated costumer reports contamination.".
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Manufacturer Narrative
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H.6 investigation summary: during manufacturing of material 221261, 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 for batch 1280969 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 no other complaints have been taken on batch 1280969 for contamination.Retention samples from batch 1280969 were not available for inspection.Three photos were received for investigation.One photo shows the agar surface of a opened plate with a large bacterial colony growing.Another photo shows the bottom of a plate from batch 1280969 (time stamp 1604) with the plate print featured for batch verification and growth visible in the plate.The last photo shows the top of an opened sleeve from batch 1280969 (time stamp 1604) with growth in the top plate.No return samples were received for investigation.A trend was identified for contamination and investigation found opportunities for bioburden reduction in the manufacturing process.A capa (corrective and preventative actions) has been initiated and involves implementing additional cleaning events and evaluation of manufacturing procedures focused on in-process bioburden reduction.Additional trainings are planned with an ongoing training review for cleaning processes.This complaint can be confirmed.Bd will continue to trend complaints for contamination.Capa #3076308 h3 other text : see h.10.
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Event Description
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It was reported that a bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) plate was contaminated.The following information was provided by the initial reporter: "quantity of product received in shipment? 23.Quantity of product affected? (please clarify the number of tubes) 1 plate.Was the contamination noticed before or after inoculation? before.Customer problem: customer reported a blood agar.Quantity received and quantity affected: 23 received and 1 plate contaminated.Costumer reports contamination".
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Search Alerts/Recalls
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