Catalog Number 221278 |
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 10/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd bbl¿ sabouraud dextrose agar (deep fill) is contaminated.Customer states the contamination is mold.No patient impact was reported.The following information was provided by the initial reporter: customer states product is contaminated.Bacteria or fungi contamination ¿ colony color? customer states mold.
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Event Description
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It was reported that bd bbl¿ sabouraud dextrose agar (deep fill) is contaminated.Customer states the contamination is mold.No patient impact was reported.The following information was provided by the initial reporter: customer states product is contaminated.Bacteria or fungi contamination ¿ colony color? customer states mold.
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Manufacturer Narrative
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H.6 investigation summary: this memo is to summarize findings regarding the complaint related to catalog number 221278, plate sabouraud dextrose agar 100 ea, batch number 2235322 and bd complaint number (b)(4) for contamination.During manufacturing of material (b)(4), 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 2235322 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 2235322.Retention samples from batch 2235322 were not available for inspection.Two photos were received for investigation.One photo shows the top of a sleeve with what appears to be fungal growth in the top plate.The other photo shows the side of a sleeve from batch 2235322 with what appears to be fungal growth in the top plate.Return samples were not received for investigation.This complaint can be confirmed for contamination.Bd has identified a contamination trend for this product.Additional trainings are planned with an ongoing training review for cleaning processes.Bd will continue to trend complaints for contamination.
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Search Alerts/Recalls
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