Model Number 221267 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2021 |
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 prior to use with bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) a plate was discovered to be contaminated.The following information was provided by the initial reporter: it was reported that customer reports contaminated plates for cat 221267 lot 1099147 what was the condition of the shipment upon receipt? no issues were seen upon initial receipt.How was the product stored? refrigerant 2-8c upon arrival.Do you have photos available showing the contamination and lot number for each affected product? not at this time.Can you please clarify the total number of boxes received for each product? lot: 1099147 number of boxes received: 9.Do you have returns available? no.Are you interested in replacement or credit? at this time, volume has not been significant for replacement product or credit.
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Event Description
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It was reported that prior to use with bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) a plate was discovered to be contaminated.The following information was provided by the initial reporter: it was reported that customer reports contaminated plates for cat 221267 lot 1099147 - what was the condition of the shipment upon receipt? no issues were seen upon initial receipt.- how was the product stored? refrigerant 2-8c upon arrival - do you have photos available showing the contamination and lot number for each affected product? not at this time.- can you please clarify the total number of boxes received for each product? lot: 1099147 number of boxes received: 9 - do you have returns available? no - are you interested in replacement or credit? at this time, volume has not been significant for replacement product or credit.
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Manufacturer Narrative
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H.6.Investigation: 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 1099147 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 1099147.Retention samples from batch 1099147 were not available for inspection.No return samples or photos were provided for investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for contamination.See h.10.
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Search Alerts/Recalls
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