Catalog Number 221267 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2023 |
Event Type
malfunction
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Event Description
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It was reported that while using the bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) that there was biological contamination 80 plates.The following information was provided by the initial reporter: chocolate agar plates were found to be contaminated on delivery.
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Manufacturer Narrative
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E.7 initial reporter addr 1: (b)(6).H.3.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 while using the bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) that there was biological contamination 80 plates.The following information was provided by the initial reporter: chocolate agar plates were found to be contaminated on delivery.
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Manufacturer Narrative
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Investigation summary: during manufacturing of material 221267, 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 3129330 was reviewed 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 for batch 3129330 was reviewed and no other complaints have been taken on the batch.No retention samples for batch 3129330 were available for inspection.No photos or return samples were received for investigation.Bd has identified a contamination trend for this product and the 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 part of the implementation with an ongoing training review for cleaning processes.Improvement in observation of contamination is expected as the capa progresses.This complaint has been confirmed based on the trend.Bd will continue to trend complaints for contamination.
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Search Alerts/Recalls
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