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

Model Number	295634
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
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 while using 6 bd bbl¿ trypticase¿ soy broths gram stain contamination was observed by the laboratory personnel.A gram stain was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that reported gram positive rod contamination.".
Additional Manufacturer Narrative
H6: investigation summary: material 295634 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 1078396 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling and torquing processes were within specifications.Qc inspection and testing was satisfactory at time of release.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 no other complaints have been taken on this batch.Retention samples from batch 1078396 (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 further investigation, two retention tubes from batch 1078396 were tested for contamination.One retention tube was incubated at 20-25 degrees celsius, and another retention tube was placed in the 33-37 degrees celsius incubator.At 7 days incubation, there was no microbial growth or turbidity in either retention tube.Two photos were received to assist with the investigation: the first photo shows a gram stain of what appears to be gram variable rods.No product information is viewed in this photo.The second photo also shows a gram stain of a gram variable rods.No product information can be viewed in this photo.Returns were received for the investigation.Four tubes from batch 1078396 were received in good condition individually bubble wrapped inside of an insulated shipping box.All four tubes had the expected appearance for this product of light to medium yellow trace, hazy to clear as describe in the certificate of analysis.For further investigation, two return samples from batch 1078396 were incubated.One return tube was placed in the 20¿25-degree celsius incubator.One return tube was placed in the 33¿37-degree celsius incubator.At 7 days incubation, there were no signs of growth the media the appearance of the media was clear.One non-incubated return tube was gram stained.The gram stain revealed gram negatives rods caution should be exercised in reporting direct gram stain and/or other direct microbiological stain results on tissue specimens processed with this medium due to the possible presence of nonviable organisms in the culture medium.Culture media sometimes contain dead organisms derived from medium constituents, which may be visible in smears of culture media.Other sources of dead organisms visible upon gram staining include staining reagents, immersion oil, glass slides, and the specimens used for inoculation.If there is uncertainty about the validity of the gram stain, the culture should be reincubated for another hour or two and the test repeated before a report is given.Bd will continue to trend complaints for appearance and non-viables.This complaint can be confirmed for non-viables.A trend has not been identified; therefore, no actions are planned at this time.
Event or Problem Description
It was reported that while using 6 bd bbl¿ trypticase¿ soy broths gram stain contamination was observed by the laboratory personnel.A gram stain was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that reported gram positive rod contamination.".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12242891
• Report Number: 1119779-2021-01230
• Device Sequence Number: 20107985
• Product Code: JSG
• UDI-Device Identifier: 30382902956342
• UDI-Public: 30382902956342
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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: 09/16/2022
• Device Model Number: 295634
• Device Catalogue Number: 295634
• Device Lot Number: 1078396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• 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