MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD BBL¿ TRYPTICASE¿ SOY BROTH; MULTIPURPOSE CULTURE MEDIUM

Catalog Number 221815

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the customer suspected a contamination of two boxes of bd bbl¿ trypticase¿ soy broth after 4 patients were tested positive for geobacillus sp.The customer indicated gram-negative rods were also present in unused media.Patient samples did not exhibit signs of bacterial growth in culture media.The physician initially based treatment on the gram stain and requested molecular 16s testing to identify the organism which returned bacillus sp.It was indicated that patients were treated for bacillus sp.There were 9 patients that were affected by this contamination.One patient was reported to have been in the pediatric intensive care unit for two week as a consequence of the results.Due diligence attempts were made to understand patient impact, how they were treated, and their current condition but no information was able to be obtained.

Event Description

This supplemental mdr is to represent the eight patients whose medical information is unknown: it was reported that the customer suspected a contamination of two boxes of bd bbl¿ trypticase¿ soy broth after 4 patients were tested positive for geobacillus sp.The customer indicated gram negative rods were also present in unused media.Patient samples did not exhibit signs of bacterial growth in culture media.The physician initially based treatment on the gram stain and requested molecular 16s testing to identify the organism which returned bacillus sp.It was indicated that patients were treated for bacillus sp.There were 9 patients that were affected by this contamination.One patient was reported to have been in the pediatric intensive care unit for two week as a consequence of the results.Due diligence attempts were made to understand the other 8 patients¿ impact, how they were treated, and their current condition but no information was able to be obtained.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Describe event updated to: this supplemental mdr is to represent the eight patients whose medical information is unknown: it was reported that the customer suspected a contamination of two boxes of bd bbl¿ trypticase¿ soy broth after 4 patients were tested positive for geobacillus sp.The customer indicated gram negative rods were also present in unused media.Patient samples did not exhibit signs of bacterial growth in culture media.The physician initially based treatment on the gram stain and requested molecular 16s testing to identify the organism which returned bacillus sp.It was indicated that patients were treated for bacillus sp.There were 9 patients that were affected by this contamination.One patient was reported to have been in the pediatric intensive care unit for two week as a consequence of the results.Due diligence attempts were made to understand the other 8 patients¿ impact, how they were treated, and their current condition but no information was able to be obtained.

Manufacturer Narrative

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 9031984 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 9031984 were available for inspection.No cap, tube or media defects were observed in 10/10 retention tubes.No appearance or microbial growth defects were found in the retention samples.Two photos were received for investigation.Both photos are micrographs of gram stains presumably of the media in question showing gram negative (pink) rods.No conclusions can be drawn from the micrographs provided.Returns were received for investigation.Three tubes from batch 9031984 were returned in a box with air bubbles in a larger box with returns for two other batches and air bubbles.No cap, tube or media defects were observed in 3/3 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 variable rods were observed in both preparations in retention and return tubes.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.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 typically found in culture media constituents.However, because this product does not have a specification for non-viable organisms the complaint cannot be confirmed.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."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." "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 re-incubated 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.Investigation conclusion: this is an unconfirmed complaint it is out of claims due to there being no specification for non-viables.Root cause description: root cause for the increase in non-viables is undetermined.

Event Description

This supplemental mdr is to represent the eight patients whose medical information is unknown: it was reported that the customer suspected a contamination of two boxes of bd bbl¿ trypticase¿ soy broth after 4 patients were tested positive for geobacillus sp.The customer indicated gram negative rods were also present in unused media.Patient samples did not exhibit signs of bacterial growth in culture media.The physician initially based treatment on the gram stain and requested molecular 16s testing to identify the organism which returned bacillus sp.It was indicated that patients were treated for bacillus sp.There were 9 patients that were affected by this contamination.One patient was reported to have been in the pediatric intensive care unit for two week as a consequence of the results.Due diligence attempts were made to understand the other 8 patients¿ impact, how they were treated, and their current condition but no information was able to be obtained.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY BROTH
• Type of Device: MULTIPURPOSE CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 250 schilling circle; cockeysville MD 21030
• MDR Report Key: 8760214
• MDR Text Key: 150117009
• Report Number: 1119779-2019-00111
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902218150
• UDI-Public: 30382902218150
• Combination Product (y/n): N
• PMA/PMN Number: PREAMEND.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/29/2020
• Device Catalogue Number: 221815
• Device Lot Number: 9031984
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 06/12/2019; 06/12/2019
• Supplement Dates FDA Received: 08/14/2019; 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention