It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1, and hemin to grind tissue samples gram-negative rods (gnr) were observed on gram stain, with no growth on culture.Several results were reported in error.Customer states three patient samples had gram negative rods in the gram stain that did not grow on culture.One patient with an aortic valve procedure did receive treatment.
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Investigation summary this product is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.The batch history record review for batch 9234989 was satisfactory per internal procedures.Formulation, filling and autoclaving processes were within specifications.Qc inspection and testing were satisfactory at time of release.The release testing that is performed on this product does include review of its color and clarity.Samples submitted are examined to ensure that they conform to typical levels.The appearance of this batch was satisfactory per internal procedures.Direct staining techniques are not part of qc release testing for this product.Additionally as part of the release criteria for this product, the bhr is reviewed to confirm the following: the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.All autoclave parameters conformed to the validated cycle parameters for this product.The minimum f0 for this product was met.The complaint history was reviewed and other complaints have been taken on this batch for appearance but are also not confirmed.Retention samples from batch 9234989 were available for inspection.No cap, tube or media defects were observed in 10/10 retention tubes.The clarity specification for this product is clear to trace hazy and all retention samples were within specifications.No appearance defects or microbial growth were found in the retention samples.Returns were received for investigation.One hundred tubes from batch 9234989 in a 100pack carton (#0142) was shipped in a box with bubble wrap and air bubbles.Tubes were inspected individually and no microbial growth or clarity defects were observed in 100/100 tubes.Other observations in the return tubes: 16 tubes were dirty on the outside from dried media but no fill volumes appeared low and one tube had black particulates (cap chips).There is no sterile claim on this product.Culture media sometimes contain dead organisms derived from medium constituents, which may be visible in smears of culture media.Other sources of dead organisms visible upon gram staining include staining reagents, immersion oil, glass slides, and the specimens used for inoculation.If there is uncertainty about the validity of the gram stain, the culture should be reincubated for another hour or two and the test repeated before a report is given.Bd will continue to trend complaints for contamination or non-viables.This complaint cannot be confirmed.Bd has confirmed the presence of non-viable organisms.However, bd cannot confirm this complaint as it is out of claims.This product does not have a specification for non-viable organisms.Due to the biological nature of the media nonviable organisms can be present.There are statements within the product insert that address the impact of nonviable organisms on the gram staining process in both the precautions and limitations of procedure sections.O "caution should be exercised in reporting direct gram stain and/or other direct microbiological stain results on tissue specimens processed with this medium due to the possible presence of nonviable organisms in the culture medium." o "culture media sometimes contain dead organisms derived from medium constituents, which may be visible in smears of culture media.Other sources of dead organisms visible upon gram staining include staining reagents, immersion oil, glass slides and the specimens used for inoculation.If there is uncertainty about the validity of the gram stain, the culture should be reincubated for another hour or two and the test repeated before a report is given.Bd has initiated capa# 1071036 which is in the investigation stage to determine what has caused the increase in non-viable organisms seen within this media.
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It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1, and hemin to grind tissue samples gram-negative rods (gnr) were observed on gram stain, with no growth on culture.Several results were reported in error.Customer states three patient samples had gram negative rods in the gram stain that did not grow on culture.One patient with an aortic valve procedure did receive treatment.
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