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

Model Number	221715
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	07/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that before using bd bbl¿ trypticase¿ soy broth was found to have bacterial contamination.The plates were not used.This is a report about contamination of the media.According to the customer's report, what appeared to be gram-positive bacillus was found in the media.The customer had experienced this issue before regardless of the lot.A gram staining was performed, however, it could not be stained.It is not growing.
Additional Manufacturer Narrative
H.6 investigation summary: material 221715 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 2026704 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 during manufacturing at designated intervals per procedures.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.Also, each batch history record is reviewed to confirm the following prior to release: --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 for contamination have been taken on this batch.Retention samples from batch 2026704 (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 incubated in the 20-25 degree c incubator and one retention tube was placed in the 33-37 degree c incubator.At the end of the seventh day of incubation there were no signs of growth or turbidity.A gram stain was also performed, and no viable organisms were found.No photos were received to assist with the investigation.No returns were received to assist with the investigation.The complaint cannot be confirmed.Bd will continue to trend complaints for contamination.
Event or Problem Description
It was reported that before using bd bbl¿ trypticase¿ soy broth was found to have bacterial contamination.The plates were not used.This is a report about contamination of the media.According to the customer's report, what appeared to be gram-positive bacillus was found in the media.The customer had experienced this issue before regardless of the lot.A gram staining was performed, however, it could not be stained.It is not growing.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY BROTH
• Common Device Name: BD BBL¿ TRYPTICASE¿ SOY BROTH
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15153687
• Report Number: 1119779-2022-01052
• Device Sequence Number: 7323447
• Product Code: JSG
• UDI-Device Identifier: 30382902217153
• UDI-Public: 30382902217153
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: 07/26/2023
• Device Model Number: 221715
• Device Catalogue Number: 221715
• Device Lot Number: 2026704
• 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: 07/11/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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