MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN; SEE H.11

Catalog Number	221742
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	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.3 common device name: culture media, non-selective and non-differential investigation summary: material 221742 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 2279224 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torquing, 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 were satisfactory at time of release.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 batch 2279224.Retention samples from batch 2279224 (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 to medium light yellow, trace hazy to clear.For investigation, two retention tubes went into incubation.One retention tube was incubated in the 20¿25-degree celsius incubator and the other tube was placed in the 33¿37-degree celsius incubator.At the seventh day of incubation there were no signs of growth or turbidity.No photos were received to assist with the investigation.Returns were received to assist with the investigation.A small shipping box was received with 15 individually bubble wrapped tubes.Five tubes were from batch 3011171, five tubes were from batch 2279224, and five tubes were from batch 2325733.The color and clarity of 5/5 returned tubes from batch 3011171 the media was medium yellow and hazy.The color and clarity from the 5/5 returned tubes from batch 2279224 was medium yellow hazy with tiny fine particles.All 5/5 returned tubes from batch 2325733 the media color and clarity was medium yellow and trace hazy as describe in the certificate of analysis.All 15/15 returned tubes were placed into 33-37-degrees celsius incubation.At the end of a seven-day incubation period there was no change in the media color and clarity.One tube was plated on to tsa 5% sheep blood agar from batch 3011171, 2279224, and batch 2325733, and no organisms were recovered.Gram stains were also performed on batch 3011171, 2279224, and batch 2279224.Gram negative rods were observed from batch 3011171 and batch 2279224, no organisms were recovered from batch 2325733.This complaint can be confirmed for contamination/appearance defects for batch 2279224 based on the evidence from the return samples received.Bd will continue to trend complaints for contamination/appearance/non-viables defects.Bd has identified a complaint trend for hazy media due to the presence of non-viables for this product.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.
Event or Problem Description
It was reported that while using the bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin, there were false results due to contamination.There was no report of patient impact.

• Brand Name: BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN
• Common Device Name: SEE H.11
• 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: 22884975
• Report Number: 1119779-2025-04318
• Device Sequence Number: 8853372
• Product Code: JSG
• UDI-Device Identifier: 30382902217429
• UDI-Public: (01)30382902217429(11)221006(17)231006(10)2279224
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K803023
• 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): 06/30/2025

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: 06/10/2023
• Device Catalogue Number: 221742
• Device Lot Number: 2279224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2023
• 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