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

Catalog Number	297354
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using one (1) bd bbl¿ trypticase¿ soy broth, the tube broke in the user's hand, when they were tightening the cap.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary - material 297354 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 5093464 was satisfactory and no quality notifications were generated during manufacturing or inspection.Formulation, filling, and autoclaving processes were within specifications.In process checks are performed during manufacturing at designated intervals per procedures.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and there are no complaint trends on batch 5093464.Retention sample inspection was performed; one loose cap and no broken tubes were observed.There was one photo submitted for review of this investigation, which showed a tube with the cap and cap area of the tube broken from the tube.This complaint can be confirmed for broken tube and loose cap.No compliant trend has been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for broken tube and loose cap defects.
Event or Problem Description
It was reported while using one (1) bd bbl¿ trypticase¿ soy broth, the tube broke in the user's hand, when they were tightening the cap.There was no health impact or consequence reported.

• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23524443
• Report Number: 1119779-2025-05233
• Device Sequence Number: 10202783
• Product Code: JSG
• UDI-Device Identifier: 30382902973547
• UDI-Public: (01)30382902973547(11)250403(17)260927(10)5093464
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: 09/27/2026
• Device Catalogue Number: 297354
• Device Lot Number: 5093464
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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