BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL
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Model Number 222239 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1099123, medical device expiration date: 2021-07-06, device manufacture date: 2021-04-09.Medical device lot #: 1106174, medical device expiration date: 2021-07-13, device manufacture date: 2021-04-16.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¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ 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: " incomplete media filling.The medium has been contaminated and discolor.".
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Manufacturer Narrative
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H6: investigation summary: during manufacturing of material 222239, 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 records for batches 1099123 and 1106174 were satisfactory and no quality notifications were generated during manufacturing and inspection of each batch.The release testing that is performed on this product does include physical attribute and bioburden testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.All physical attribute and bioburden testing performed on these batches were 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 other complaints have been taken on batches 1099123 and 1106174 from other customers.Retention samples from batches 1099123 and 1106174 were not available for inspection.Four photos were received for investigation.--one photo shows the bottom of 20 plates from batch 1099123 (time stamps not readable) with microbial growth visible in at least one media of each plate.--one photo shows the bottom of a plate from batch 1099123 (time stamp 1557) with microbial growth in the tsa with 5% sheep blood.--one photo shows the bottom of two plates 1106174 (time stamps 0717 and 0734) with microbial growth in tsa with 5% sheep blood of one plate and chromagar orientation of the other plate.--one photo shows the bottom of a plate from batch 1099123 (time stamp 1608) with what microbial growth in the chromagar orientation medium.The photos did not show plates with any filling defects.No return samples were received for investigation.This complaint can be confirmed for contamination in batches 1099123 and 1106174 by the photos provided.However, media splash over has been confirmed in batches 1099123 and 1106174 from photos in other complaints taken on these batches.Due to the number of complaints taken for contamination for material 222239, a capa (corrective and preventative actions) 3076308 has been initiated to determine the root cause and corrective actions of the contamination.Bd will continue to trend complaints for these defects.
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Event Description
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It was reported that while using bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ 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: " 1.Incomplete media filling.2.The medium has been contaminated and discolor.".
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Search Alerts/Recalls
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