Model 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 08/29/2021 |
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 while using bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " customer reports plates contaminated with mold for cat 221267 lot 1152688.".
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Event Description
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It was reported that while using bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " customer reports plates contaminated with mold for cat 221267 lot 1152688.".
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Manufacturer Narrative
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H6: 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 1152688 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 1152688.Retention samples from batch 1152688 were not available for inspection.Ten plates from batch 1152688 were returned as one unopened sleeve shipped in a box with bubble wrap.Plates were inspected and 1/10 returned plates had surface fungal growth (time stamp 1106).The plate was submitted to the id lab and penicillium species was identified.Two photos also were received for investigation.One photo shows the surface of an opened chocolate-brown agar plate with a microbial colony growing.The other photo shows the surface of a chocolate-brown agar plate with a large fungal colony and other smaller colonies growing.This complaint can be confirmed.A trend was identified for contamination and investigation found opportunities for bioburden reduction in the manufacturing process.A capa (corrective and preventative actions) 3076308 has been initiated and involves implementing additional cleaning events and evaluation of manufacturing procedures focused on in-process bioburden reduction.H3 other text : see h10.
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Search Alerts/Recalls
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