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BECTON, DICKINSON & CO. (SPARKS) SEE H.10; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL
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| Catalog Number 222239 |
| 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 01/27/2021 |
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Event Type
malfunction
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Manufacturer Narrative
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Medical device brand name: bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿."multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0274482, medical device expiration date: 2020-12-29, device manufacture date: 2020-09-30.Medical device lot #: 0297666, medical device expiration date: 2021-01-22, device manufacture date: 2020-10-23.Medical device lot #: 0304080, medical device expiration date: 2021-01-28, device manufacture date: 2020-10-30.Medical device lot #: 0316614, medical device expiration date: 2021-02-08, device manufacture date: 2020-11-11.Medical device lot #: 0260495, medical device expiration date: 2020-12-14, device manufacture date: 2020-09-16.Medical device lot #: 0324225, medical device expiration date: 2021-02-22, device manufacture date: 2020-11-19.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¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ plates were contaminated with multiple lots.0297666 bacterial contamination 8 plates, 0274482 bacterial contamination 13 plates, 0316614 bacterial contamination 3 plates, 0324225 bacterial contamination 1 plate, 0260495 bacterial contamination 4 plates, 0324225 bacterial contamination 9 plates, 0316614 bacterial contamination 2 plates, 304080 bacterial contamination 3 plates.
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Manufacturer Narrative
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H.6.Investigation: 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 record review for batches 0297666, 0274482, 0316614, 0324225, 0260495 and 0304080 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 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 batches 0297666, 0274482, 0316614, 0260495 and 0304080.The only other complaints on batch 00324225 also were taken from this customer and also were for contamination.Retention samples from batches 0297666, 0274482, 0316614, 0324225, 0260495 and 0304080 were not available for inspection.Twelve photos were received for investigation.--one photo shows the bottom of a taped plate from batch 0324225 (time stamp 1051) with microbial growth on both media.The media is also mixed in one bi-plate half and not completely filling the bottom of the other bi-plate half.Media splash over is a filling defect were the two media of a bi-plate are mixed in at least one half of the bi-plate.This results in media appearing discolored and unevenly filled halves of the bi-plate.--two photos each show stacks of bi-plates from batch 0324225 (time stamp 1059) with cracks visible in the plate lids.--one photo shows the bottom of a plate from batch 0324225 (time stamp 1059) with a label designating cracked plates.No cracks can be seen in the photo.--one photo shows the bottom of four taped plates from batch 0324225 (time stamps 2055, 2114, 2117 and 2204) with one microbial colony visible on the chromagar orientation medium of each plate (same photo from complaint 2354857).--one photo shows the bottom of two taped plates from batch 0316614 (time stamp 0730) with microbial growth on the tsa with 5% sb medium of each plate.--one photo shows the bottom of a taped plate from batch 0316614 (time stamp 0652) with microbial growth in the tsa with 5% sb medium.--one photo shows the bottom of three taped plates from batch 0304080 (time stamp 1740) with microbial growth visible in the tsa with 5% sb medium.--one photo shows the bottom of a plate from batch 0274482 (time stamp 1152) with microbial growth in the tsa with 5% sb medium.--one photo shows the bottom of six taped plates with microbial growth visible in at least one medium of each plate.The plate prints in the photo are not readable for batch verification.--one photo shows the bottom of four taped plates from batch 0260495 (time stamp 1024) with microbial growth visible in at least one medium of each plate.--one photo shows the bottom of a taped plate from batch 0297666 (time stamp 0553) with a label designating 3 cracked plates.However, no cracks can be seen in the photo.No return samples were received for investigation.To summarize, the photos show contamination in plates of batches 0274482, 0316614, 0324225, 0260495 and 0304080, splash over (uneven fill) in a plate of batch 0324225 and broken plates of batch 0324225.The photos do not show contamination in plates of batch 0297666 or broken plates of batch 0297666.Bd ships product in temperature-controlled trucks to distribution centers.Distribution centers are provided with shipping and storage guidelines.Dropping of the plates and vibrations during shipping can cause broken or cracked plates.However, the root cause of the broken plates observed cannot be determined at this time.This complaint has been confirmed for contamination in batches 0274482, 0316614, 0324225, 0260495 and 0304080.This complaint cannot be confirmed for contamination in batch 029766.This complaint can be confirmed for broken plates in batch 0324225.This complaint cannot be confirmed for broken plates in batch 0297666.This complaint can be confirmed for splash over (uneven fill) in batch 0324225.Bd will continue to trend complaints for broken plates and contamination.Based on the low defect rate, no actions are planned at this time for broken plates or splash over.Due to the number of complaints taken for contamination for material 222239, capa#3076308 has been initiated to determine the root cause and corrective actions of the contamination.H3 other text : see h.10.
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Event Description
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It was reported that prior to use with bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ plates were contaminated with multiple lots.0297666 bacterial contamination 8 plates, 0274482 bacterial contamination 13 plates, 0316614 bacterial contamination 3 plates, 0324225 bacterial contamination 1 plate, 0260495 bacterial contamination 4 plates, 0324225 bacterial contamination 9 plates, 0316614 bacterial contamination 2 plates, 304080 bacterial contamination 3 plates.
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