MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY BROTH; SEE H.10

Model Number	297354
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	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: culture media, non-selective and non-differential.Medical device lot #: 2146742.Medical device expiration date: 2023-11-22.Device manufacture date: 2022-05-26.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 that while using the bd bbl¿ trypticase¿ soy broth that there was contamination.The following information was provided by the initial reporter: customer is reporting 2 contaminated media for item 297354, lot #¿s 2146742 & 2209307.
Event or Problem Description
It was reported that while using the bd bbl¿ trypticase¿ soy broth that there was contamination.The following information was provided by the initial reporter: customer is reporting 2 contaminated media for item 297354, lot #¿s 2146742 & 2209307.
Additional Manufacturer Narrative
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.Batch 2146742.The batch history record review for batch 2146742 was satisfactory per internal procedures.Formulation, filling, and packaging processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch for contamination.Retention samples from batch 2146742 (10 tubes) were available for inspection.Two retention tubes went into incubation.One tube was placed into 33-37-degrees celsius incubation and one tube was placed into 20-25-degrees celsius incubation.At the end of a seven-day incubation period no microbial growth was observed in 2/2 incubated retention tubes.Batch 2209307.The batch history record review for batch 2209307 was satisfactory per internal procedures.Formulation, filling, and packaging processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch for contamination.Retention samples from batch 2209307 were not available for inspection.No photos were received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed for either of the complaint batches.Bd will continue to trend complaints for contamination.H3 other text : see h.10.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY BROTH
• Common Device Name: SEE H.10
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16504523
• Report Number: 1119779-2023-00242
• Device Sequence Number: 3352021
• Product Code: JSG
• UDI-Device Identifier: 30382902973547
• UDI-Public: 30382902973547
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 01/25/2024
• Device Model Number: 297354
• Device Catalogue Number: 297354
• Device Lot Number: 2209307
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• 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