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BECTON, DICKINSON & CO. BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1, AND HEMIN; MULTIPURPOSE CULTURE MEDIUM
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| Catalog Number 221788 |
| Device Problems
Material Opacification (1426); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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| Event Date 06/02/2019 |
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Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1, and hemin, gram-negative rods (gnr) were observed and used which resulted in erroneous results being reported out to the physician for 4 patients.The customer indicated that the tubes were slightly turbid.When subculturing the tubes, the organisms will not grow aerobically or anaerobically.The customer indicated gnrs were also present in the unused media.No other details of the course of treatment or medication for the 4 patients was able to be obtained.
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Event Description
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It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1, and hemin, gram-negative rods (gnr) were observed and used which resulted in erroneous results being reported out to the physician for 4 patients.The customer indicated that the tubes were slightly turbid.When subculturing the tubes, the organisms will not grow aerobically or anaerobically.The customer indicated gnrs were also present in the unused media.No other details of the course of treatment or medication for the 4 patients was able to be obtained.
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Manufacturer Narrative
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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 9051899 was satisfactory and no notifications were generated during manufacturing and inspection.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 unconfirmed.Retention samples from batch 9051899 were available for inspection.No cap, tube or media defects were observed in 10/10 retention tubes.No appearance defects or microbial growth were found in the retention samples.Returns were received for investigation.Nine tubes from batch 9051899 were parafilmed, wrapped in a bubble wrap and shipped in an insulated shipping box.One returned tube had less than expected media in the tube and one tube was missing a tube label.The clarity of the returned media was slightly hazy.No other cap, tube or media defects were observed in 9/9 return samples.For investigation of this complaint, retention and return samples were gram stained by two methods: 1) directly dropping the media on a slide and 2) by cytospin preparation.Gram negative rods and gram positive cocci were observed in the direct drop and cytospin preparation of the return sample.No organisms were observed in both retention sample stains.Additional retention and return tubes were incubated at 33-37°c for three days and then moved to a 55-60°c incubator for an additional seven days.No microbial growth in the form of turbidity in the media was observed after neither the 33-37°c incubation period nor the 55-60°c incubation period.After the 55-60°c incubation, tubes were gram stained, by direct drop, and then plated to non-selective media that was incubated at 33-37°c and 55-60°c for an additional seven days.The gram stains did not show any significant increase in organisms seen compared to non-incubated stains and no microbial growth was observed in any of the plates.Though non-viable organisms were observed in some of the gram stains, this is not an unexpected observation.Please refer to the package insert for product information.Bd will continue to trend complaints for contamination or non-viables.This complaint cannot be confirmed.
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Manufacturer Narrative
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Correction: medical device manufacturer becton, dickinson & co.250 schilling circle, cockeysville, md, 21030.Phone: +1(410)773-6076.Manufacturing location: becton, dickinson & co.250 schilling circle cockeysville, md, 21030.Phone: +1(410)773-6076.
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Event Description
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It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1, and hemin, gram-negative rods (gnr) were observed and used which resulted in erroneous results being reported out to the physician for 4 patients.The customer indicated that the tubes were slightly turbid.When subculturing the tubes, the organisms will not grow aerobically or anaerobically.The customer indicated gnrs were also present in the unused media.No other details of the course of treatment or medication for the 4 patients was able to be obtained.
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