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

Model Number	221823
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 while using bd bbl¿ trypticase¿ soy broth there was bacillus cereus contamination in one tube.There was no report of patient impact.The following information was provided by the initial reporter: "contamination was noticed after inoculation.Contamination id'd as bacillus cereus group using 16s rdna identification.Media was subcultured to tsa, culture was positive.Gram stain performed manually.".
Event or Problem Description
It was reported that while using bd bbl¿ trypticase¿ soy broth there was bacillus cereus contamination in one tube.There was no report of patient impact.The following information was provided by the initial reporter: "contamination was noticed after inoculation.Contamination id'd as bacillus cereus group using 16s rdna identification.Media was subcultured to tsa, culture was positive.Gram stain performed manually.".
Additional Manufacturer Narrative
H.6 investigation summary: material 221823 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 2258392 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 no other complaints have been taken on this batch.Retention samples from batch 2258392 (10 tubes) were available for inspection.No media defects were observed in 10/10 retention samples.All retention tubes had the expected appearance for this product of light yellow to medium tan, yellow, trace hazy to clear.For investigation, two retention tubes went into incubation.One retention tube was placed into 20-25-degrees celsius, and one retention tube was placed into 33-37-degrees celsius.At the end of a seven day incubation period no microbial growth or change in the media color/clarity was observed in 2/2 incubated retention tubes.No photos were received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for contamination/appearance defects.Caution should be exercised in reporting direct microbiological stain or molecular testing directly using 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 or detectible by molecular testing.Product should not be used if medium shows evidence of contamination, discoloration, drying or other signs of deterioration.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17299624
• Report Number: 1119779-2023-00764
• Device Sequence Number: 7061306
• Product Code: JSG
• UDI-Device Identifier: 30382902218235
• UDI-Public: 30382902218235
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 10/10/2023

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: 03/17/2024
• Device Model Number: 221823
• Device Catalogue Number: 221823
• Device Lot Number: 2258392
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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