BECTON, DICKINSON & CO. (SPARKS) BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II); CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
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Catalog Number 221261 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2021 |
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.(b)(4).
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Event Description
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It was reported that prior to use with bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) 50 plates were discovered to have bacterial contamination.
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Event Description
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It was reported that prior to use with bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) 50 plates were discovered to have bacterial contamination.
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Manufacturer Narrative
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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 8o 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 0289052 was satisfactory at time of release 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 this batch for contamination by another customer.Retention samples from batch 0286052 were not available for inspection.No returns or photos were received for investigation of this complaint.However, photos-in-lieu-of-returns from another customer showed contamination in batch 0286052.This complaint has been confirmed.Bd will continue to trend complaints for contamination.Based on the low defect rate for the batch in question, no actions are planned at this time.
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Search Alerts/Recalls
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