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

Catalog Number	221716
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bbl¿ trypticase¿ soy broth contamination was observed.There was no patient impact.The following was rpeorted by the initial reporter: according to the customer's report, recently, in smear tests using the broth, a small amount of g+r or g-r are indistinctly observed.Today, a gram staining was performed with centrifugal sedimentation from several unused tubes, and g-r was observed.The bacteria was found in the lower part of the tubes.No bacteria was found in the upper part.The customer suspects environmental bacteria.Occurred with 5 plates.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: the batch history record review for batch 3005708 was satisfactory per internal procedures.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: 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 3005708 (10 tubes) were available for inspection.No cap, tube, or 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 tube was placed in 20-25-degree celsius incubation and one tube was placed in 33-37-degrees celsius incubation.At the end of a seven-day incubation period no microbial growth was observed in 2/2 incubated retention tubes.No photos or returns were received to assist with the investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for contamination/appearance and non-viable defects.
Event or Problem Description
It was reported that while using bd bbl¿ trypticase¿ soy broth contamination was observed.There was no patient impact.The following was rpeorted by the initial reporter: according to the customer's report, recently, in smear tests using the broth, a small amount of g+r or g-r are indistinctly observed.Today, a gram staining was performed with centrifugal sedimentation from several unused tubes, and g-r was observed.The bacteria was found in the lower part of the tubes.No bacteria was found in the upper part.The customer suspects environmental bacteria.Occurred with 5 plates.
Event or Problem Description
It was reported while using bd bbl¿ trypticase¿ soy broth, a plate was contaminated.There was no report of patient impact.
Additional Manufacturer Narrative
The following fields have been updated: b5.It was reported while using bd bbl¿ trypticase¿ soy broth, a plate was contaminated.There was no report of patient impact.This supplemental mdr is being submitted as part of a retrospective review of records dating (b)(6) 2023¿2025, under capa 11910483.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17725555
• Report Number: 1119779-2023-00977
• Device Sequence Number: 20588669
• Product Code: JSG
• UDI-Device Identifier: 30382902217160
• UDI-Public: 30382902217160
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2025

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: 07/04/2024
• Device Catalogue Number: 221716
• Device Lot Number: 3005708
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 11/01/2023; 09/10/2025
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 11/27/2023; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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