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

Model Number	221815
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	06/11/2021
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 100 bd bbl¿ trypticase¿ soy broth bacterial contamination was observed by the laboratory personnel.A gram stain test 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: "this is a report about contamination of the media.".
Event or Problem Description
It was reported that while using 100 bd bbl¿ trypticase¿ soy broth bacterial contamination was observed by the laboratory personnel.A gram stain test 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: "this is a report about contamination of the media.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes, d10: returned to manufacturer on: 2021-06-18.H6: investigation summary : the batch history record review for batch 1070138 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 at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per procedure.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: 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 three other complaints have been taken on this batch for contamination.Retention samples from batch 1070138 (10 tubes) were available for inspection.There was no observable evidence of sedimentation or turbidity from visual inspection of 10/10 tubes.For further testing, two retentions tubes were incubated.One tube was placed at 20¿25-degrees celsius incubator and one tube was placed into 33-37 degrees celsius incubator.At the seven days incubation, no microbial growth or sedimentation was observed in 2/2 tubes.Returns were received to assist with the investigation.Received four tubes in a plastic bag from batch 1070138 in a shipping box.The tubes were received in good condition, the media in all four tubes was hazy in appearance.For further testing, two return tubes were incubated.One tube was placed at 20¿25-degrees celsius incubator and one tube was placed into 33-37 degrees celsius incubator.At the seven days incubation, no microbial growth was observed in 2/2 tubes.The hazy appearance was consistent with sedimentation.The media was also plated on tsa 5% sb media and no microbial growth was observed after three days incubation.The certification of analysis states the broth is clear to trace hazy.The haziness and sedimentation is a result of the biological components used to manufacture the dried culture media.This complaint cannot be confirmed based on the returns received.Bd will continue to trend complaints for contamination.H3 other text : see h10.

• 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: 12125493
• Report Number: 1119779-2021-01134
• Device Sequence Number: 19775047
• Product Code: JSG
• UDI-Device Identifier: 30382902218150
• UDI-Public: 30382902218150
• 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
• Report Date (Section B): 01/10/2022

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: 09/03/2022
• Device Model Number: 221815
• Device Catalogue Number: 221815
• Device Lot Number: 1070138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• 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