MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number	221788
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	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin, there was a false result due to contamination.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: material 221788 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 2349886 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation and filling 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 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 contamination/appearance non-viable defects.Retention samples from batch 2349886 (10 tubes) were available for inspection.No media defects were observed in 10/10 retention samples from visual inspection.For investigation, two retention tubes went into incubation from batch 2349886.One tube was incubated in the 20-25 degrees celsius incubator, and one tube was placed in the 33¿37-degree celsius incubator.At the seventh day of incubation there were no signs of turbidity or microbial growth.There was no change in the color and clarity in of the media.The media remained medium light-yellow and clear to trace hazy.A gram stain was performed on one tube, and no organisms were recovered.The media was also plate onto tsa 5% sheep blood agar and no organisms were recovered at 33 to 37 degrees c at 3 days incubation.Four photos were received to assist with the investigation: --one photo shows the label of a partial 100-pack carton from batch 2349886.--two photos show a gram stain of gnr¿s.--the last photo shows one tube from batch 2349886.The media color and clarity appear clear yellow as described in the certificate of analysis.Non-viable organisms are acknowledged in batch 2349886 however, the clarity of the media was within specification.This complaint cannot be confirmed for a contamination/appearance non-viable defect.Bd has identified a complaint trend for hazy media due to the presence of non-viables for this product.A capa (corrective and preventative actions) has been initiated per bd procedures.Bd will continue to trend complaints for contamination.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.

• Brand Name: BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22784340
• Report Number: 1119779-2025-03029
• Device Sequence Number: 12826032
• Product Code: JSG
• UDI-Device Identifier: 30382902217887
• UDI-Public: (01)30382902217887(11)221215(17)231216(10)2349886
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K803025
• 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
• Report Date (Section B): 07/02/2025

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: 12/16/2023
• Device Catalogue Number: 221788
• Device Lot Number: 2349886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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