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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd bbl¿ trypticase¿ soy broth performance issue insufficient growth.The following information was provided by the initial reporter: we had performed growth promotion testing on 2 lots of cat#297354 media, bd bbl trypticase soy broth, 100x10ml using staphylococcus aureus from bioball nctc 10788 and microbiologics accushots atcc 6538, and we were unable to obtain any growth in the media.Would like to check if any of the other companies feedback to you on this issue? kindly advise soon.Troubleshooting done: analysts technique (still occurs when experienced analysts runs the test) the brand of microorganisms (same outcome with different brands of sa were used.Other media do not have recovery issue) lot specificity (at least 2 lots of tsb from bd have had this issue) i understand that manufacturers would have established its product shelf life through rigorous testing at different lifecycle of the product.Besides the initial release testing for each routine lot, how often is this being verified ?.
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot#: 1258151 medical device expiration date: 15-mar- 2023.Device manufacture date: 15-sep-2021.Medical device lot#: 1174721 medical device expiration date: 18-dec-2022.Device manufacture date: 23-june-2021.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
After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2022-01395 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.H3 other text : see h.10.
Event or Problem Description
T was reported that bd bbl¿ trypticase¿ soy broth performance issue insufficient growth.The following information was provided by the initial reporter: we had performed growth promotion testing on 2 lots of cat#297354 media, bd bbl trypticase soy broth, 100x10ml using staphylococcus aureus from bioball nctc 10788 and microbiologics accushots atcc 6538, and we were unable to obtain any growth in the media.Would like to check if any of the other companies feedback to you on this issue? kindly advise soon.Troubleshooting done: - analysts technique (still occurs when experienced analysts runs the test) - the brand of microorganisms (same outcome with different brands of sa were used.Other media do not have recovery issue).- lot specificity (at least 2 lots of tsb from bd have had this issue).- i understand that manufacturers would have established its product shelf life through rigorous testing at different lifecycle of the product.Besides the initial release testing for each routine lot, how often is this being verified ?.

• 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: 15811034
• Report Number: 1119779-2022-01395
• Device Sequence Number: 12165650
• Product Code: JSG
• UDI-Device Identifier: 30382902973547
• UDI-Public: 30382902973547
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: NA
• 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): 12/14/2022

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 Model Number: 297354
• Device Catalogue Number: 297354
• Device Lot Number: SEE H.10
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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