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

Model Number	297354
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there are visible signs of contamination with microbial growth, within bd bbl¿ trypticase¿ soy brothtube.Confirmatory testing performed: ¿the microbial identification of this microorganism is acinetobacter species.¿ the following information was provided by the initial reporter: ¿to be clear: 1 tube was found to be contaminated.¿.
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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 31-mar-2022.H6: 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 1266853 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling and torquing processes were within specifications.In process checks were performed during manufacturing at designated intervals per procedures.Checks for fill volume were complete and within specifications per procedures.Qc inspection and testing were satisfactory at time of release.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 1266853 (10 tubes) were available for inspection.No media defects were observed in 10/10 retention samples.There was no evidence of contamination from visual inspection.Two retention tubes were incubated.One retention tube was placed not 20-25 degrees celsius, and one retention tube was placed into 33-37 degrees celsius.At the end of a seven-day incubation period there was no evidence of microbial growth.Two photos were received to assist with the investigation: ¿ the first photo shows two partial tubes.Only the bottom of the tubes can be observed.The media in both tubes appear hazy or appear to have sedimentation.¿ the second photo shows one tube from batch 1266853.The media does appear to be hazy.Returns were received to assist with the investigation.Fourteen tubes were received, in a tube rack, inside of a plastic bag, in a shipping box with packing bubbles.All fourteen tubes were from batch 1266853.All fourteen tubes were received in good condition.There was no evidence of contamination from visual inspection.The return tubes were incubated.Seven return tubes were placed into 20-25 degrees celsius, and seven return tubes were placed into 33-37 degrees celsius.At the end of a seven-day incubation period there was no evidence of microbial growth or turbidity of the media.Two return tubes were also plated on 5% tsa sheep blood media.One return tube was plated and incubated at 20-25 degrees celsius.One return tube was plated and incubated at 33-37 degree celsius.At the end of a seven-day incubation period, no microbial growth was observed on either plate.The complaint can be confirmed based on the evidence from the photos provided by the customer.The returns the color and clarity of the media was within specifications of the certificate of analysis: light yellow, to medium tan yellow, clear to trace hazy.
Event or Problem Description
It was reported that there are visible signs of contamination with microbial growth, within bd bbl¿ trypticase¿ soy brothtube.Confirmatory testing performed: ¿the microbial identification of this microorganism is acinetobacter species.¿ the following information was provided by the initial reporter: ¿to be clear: 1 tube was found to be contaminated.¿.

• 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: 14059875
• Report Number: 1119779-2022-00544
• Device Sequence Number: 11950117
• Product Code: JSG
• UDI-Device Identifier: 30382902973547
• UDI-Public: (01)30382902973547
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• 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): 06/15/2022

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: 03/22/2023
• Device Model Number: 297354
• Device Catalogue Number: 297354
• Device Lot Number: 1266853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2021
• 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