MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY BROTH; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number	221716
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd bbl¿ trypticase¿ soy broth contaminate media occurred.Several cultures were reported with no subsequent growth on the plates.The following information was provided by the initial reporter: we used this broth for grinding our tissues from the operating room.Gram stains of the ground specimen showed large decolorizing gram positive rods which were reported in a number of cultures, with no subsequent growth on the plates.We did a cytospin of the broth which showed these rods in the uninoculated tsb broth.I know bd guarantees sterility, but not that there will be no non-viable organisms.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd bbl¿ trypticase¿ soy broth contaminate media occurred.Several cultures were reported with no subsequent growth on the plates.The following information was provided by the initial reporter: we used this broth for grinding our tissues from the operating room.Gram stains of the ground specimen showed large decolorizing gram positive rods which were reported in a number of cultures, with no subsequent growth on the plates.We did a cytospin of the broth which showed these rods in the uninoculated tsb broth.I know bd guarantees sterility, but not that there will be no non-viable organisms.
Additional Manufacturer Narrative
H.6 investigation summary: material 221716 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 2272714 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, and autoclaving processes were within specifications.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing was satisfactory at time of release.As part of the release criteria for this product, the bhr is reviewed to confirm the following: 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 one other complaint has been taken on this batch.Retention samples from batch 2272714 (10 tubes) were available for inspection.No media defects were observed in 10/10 retention samples.All retentions tubes had the expected appearance for this product of light to medium light yellow, trace hazy to clear.For investigation, two retention tubes went into incubation from batch.One tube went into 20-25-degree celsius incubation, and one tube went into the 33-37-degree celsius incubation.At the end of a seven-day incubation period no microbial growth was observed.A gram stain was performed on the retention sample and no organisms were recovered.No photos were received to assist with the investigation.Returns were received to assist with the investigation.One-hundred tubes from batch 2272714 were received in a bd carton in a large shipping box with tissue paper.All 100/100 returned tubes had sedimentation when the media was swirled.The color and clarity of the media was light to medium light-yellow trace hazy to clear as described in the certificate of analysis.All 100/100 returned tubes were incubated at 33-37-degrees celsius.At the end of a seven-day incubation period no microbial growth or turbidity of the media was observed in 100/100 returned tubes.The color and clarity of the media after incubation was light to medium light-yellow trace hazy to clear as described in the certificate of analysis.A gram stain was performed no organisms were recovered.The media was also plated onto tsa 5% sheep blood agar and no organisms were recovered.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 reincubated for another hour or two and the test repeated before a report is given.Additionally, this product is not labeled sterile.As stated in our package insert, "do not use medium if it shows evidence of microbial contamination, discoloration, drying or other signs of deterioration".A complaint trend was not identified for contamination, including non-viables, or appearance in this product per bd procedures.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY BROTH
• Common Device Name: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16262095
• Report Number: 1119779-2023-00085
• Device Sequence Number: 17227888
• Product Code: JSG
• UDI-Device Identifier: 30382902217160
• UDI-Public: 30382902217160
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/23/2024
• Device Model Number: 221716
• Device Catalogue Number: 221716
• Device Lot Number: 2272714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 01/29/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown