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

Model Number	221716
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using 100 bd bbl¿ trypticase¿ soy broth contamination was observed by the laboratory personnel.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: this is a report about contamination of the media.According to the customer's information, negative bacillus was found to have grown during a gram staining performed directly from the broth.(b)(6) on (b)(6) 2022.On 05may2022/ (b)(4) - additional information provided from task: did the customer find biological growth - did the organism grow on their media? yes or no? they did not culture the media.But they assumed these were non-viable organisms.If no then please clarify if what they are seeing are non-viables in the tube.When sample is plated there is no growth seen.Since reported during use need the following answered: were any erroneous results reported on any patient samples? yes.If so were any patients treated based on the erroneous results? unknown.Any other patient impact? unknown.
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 2 bd bbl¿ trypticase¿ soy broth contamination was observed by the laboratory personnel.A repeat test was performed using a subculture and the results were negative.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: " this is a report about contamination of the media.According to the customer's information, negative bacillus was found to have grown during a gram staining performed directly from the broth.(b)(6) on (b)(6) 2022.Photos are attached in "attachment(s)" 05may2022/pw - additional information provided from task: 1) did the customer find biological growth - did the organism grow on their media ? yes or no? => they did not culture the media.But they assumed these were non-viable organisms 2) if no - then please clarify if what they are seeing are non-viables in the tube => when sample is plated - there is no growth seen 3) since reported 'during use" - need the following answered: - were any erroneous results reported on any patient samples? => yes.- if so - were any patients treated based on the erroneous results? => unknown - any other patient impact? => unknown".
Additional Manufacturer Narrative
The following fields were updated with additional information: b.5.Event description: it was reported that while using 2 bd bbl¿ trypticase¿ soy broth contamination was observed by the laboratory personnel.A repeat test was performed using a subculture and the results were negative.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: " this is a report about contamination of the media.According to the customer's information, negative bacillus was found to have grown during a gram staining performed directly from the broth.(b)(6) on (b)(6) 2022.Photos are attached in "attachment(s)" 05may2022/pw - additional information provided from task: 1) did the customer find biological growth - did the organism grow on their media ? yes or no? => they did not culture the media.But they assumed these were non-viable organisms 2) if no - then please clarify if what they are seeing are non-viables in the tube => when sample is plated - there is no growth seen 3) since reported 'during use" - need the following answered: - were any erroneous results reported on any patient samples? => yes.- if so - were any patients treated based on the erroneous results? => unknown - any other patient impact? => unknown".
Additional Manufacturer Narrative
H.6 investigation summary: material 221716 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 1123397 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torquing, and autoclaving 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 1123397 (10 tubes) were available for inspection.No evidence of contamination was 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 2 retention tubes were incubated.One tube was placed into 33-37-degree celsius incubation, and one tube was placed into 20-25-degree celsius incubation.At the end of a seven-day incubation period there was no microbial growth or change in the media clarity in 2/2 incubated retention tubes.Eight photos were received to assist with the investigation: the first photo shows the caps of eighty tubes in a tube rack.The second photo shows the media of the tubes.The media appears medium yellow clear as described in the certificate of analysis.The third photo shows tubes from batch 1123397, in a tube rack.The media appears medium yellow clear as described in the certificate of analysis.The fourth photo verifies that the tubes are from batch 1123397.The fifth photo shows the bottom of a tube.The tube has a crack.The sixth photo shows a gram stain of gram variable rods.The seventh photo also shows a gram stain of gram variable rods.The last photo also shows a gram stain of gram variable rods.Returns were received for the investigation.Sixty-six tubes from batch 1123397 were received in a shipping box.One tube was received cracked and 65 tubes were received in good condition with no evidence of contamination/turbidity.For further investigation, return tubes were incubated.Thirty-two return tubes were incubated in the 20-25 degree c incubator, and 32 return tubes was placed in the 33-37 degree c incubator.At 7 days incubation, there were no signs of growth or turbidity in 65/65 returned tubes.One tube was not incubated and used to perform gram stain.No viable organisms found the gram stain consisted of gram variable 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.No actions are indicated at this time due to no trends observed for this defect.Bd will continue to trend complaints for contamination and non-viables.This complaint can be confirmed for non-viables.Notes: risk management review indicates the potential risk of the defect reported was assessed as severity [s2], per [baltrmterminalgpaph ], rev [02], id [2.23].
Event or Problem Description
It was reported that while using 100 bd bbl¿ trypticase¿ soy broth contamination was observed by the laboratory personnel.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: " this is a report about contamination of the media.According to the customer's information, negative bacillus was found to have grown during a gram staining performed directly from the broth.(b)(6) on (b)(6) 2022.05may2022/pw additional information provided from task: 1) did the customer find biological growth did the organism grow on their media ? yes or no? they did not culture the media.But they assumed these were non-viable organisms.2) if no then please clarify if what they are seeing are non-viables in the tube.When sample is plated there is no growth seen.3) since reported 'during use" need the following answered: were any erroneous results reported on any patient samples? yes.If so - were any patients treated based on the erroneous results? unknown.- any other patient impact?: unknown.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14413970
• Report Number: 1119779-2022-00701
• Device Sequence Number: 5451186
• 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): 08/25/2022

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: 10/26/2022
• Device Model Number: 221716
• Device Catalogue Number: 221716
• Device Lot Number: 1123397
• 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: 04/19/2022
• Supplement Date Received by Manufacturer: 05/17/2022; 08/25/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 05/18/2022; 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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