MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) SEE H.11; 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	05/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D1: medical device brand name: bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin.E1.Initial reporter email: (b)(6).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 2251073 was satisfactory per internal procedures.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.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.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 complaint have been taken on this batch.Retention samples from batch 2251073 (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.One retention tube was placed into the 20¿25-degree celsius incubator and one retention tube was placed in the 33¿37-degree celsius incubator.At the seventh day of incubation there were no signs of growth or turbidity.There was no change in the color and clarity in of the media.The media remained medium yellow clear to trace hazy as described in the certificate of analysis.Four photos were received to assist with the investigation: the first photo shows the media of a partial tube.The cap cannot be seen in the photo.The media appears medium yellow trace hazy as described in the certificate of analysis.No product information is presented in the photo.Three photos show gram stains of gnr¿s.Without product verification a photo alone cannot confirm a complaint.A photo must provide the product, product defect, and clear indication of the batch/lot number must be included in the photo.No returns were received to assist with the investigation.This complaint cannot be confirmed.The color and clarity of the media on batch 2251073 is light to medium light yellow, trace hazy to clear as described in the certificate of analysis.As stated in the ifu for material 221788 (available on bd.Com/e-labeling), this media should be reduced by boiling prior to use.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 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.

• Brand Name: SEE H.11
• 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: 22922346
• Report Number: 1119779-2025-04321
• Device Sequence Number: 10230759
• Product Code: JSG
• UDI-Device Identifier: 30382902217887
• UDI-Public: (01)30382902217887(11)220908(17)230906(10)2251073
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Foreign,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: 09/06/2023
• Device Catalogue Number: 221788
• Device Lot Number: 2251073
• 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: 05/04/2023
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2022
• 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