Model Number 221291 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2021 |
Event Type
malfunction
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Event Description
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It was reported that there was 1 sleeve of bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) // macconkey ii agar that had biological contamination.The following information was provided by the initial reporter: customer reported 1 sleeve with biological contamination of product 221291 with lot#: 1253729.
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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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Manufacturer Narrative
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H.6 investigation summary: during manufacturing of material 221291, 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 1253729 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 1253729 for contamination.Retention samples from batch 1253729 were not available for inspection.No returns samples or photos were received for investigation of this complaint.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 by the trend identified.Bd will continue to trend complaints for contamination.Capa #3076308.
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Event Description
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It was reported that there was 1 sleeve of bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) // macconkey ii agar that had biological contamination.The following information was provided by the initial reporter: customer reported 1 sleeve with biological contamination of product 221291 with lot#: 1253729.
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Search Alerts/Recalls
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