MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ GROUP A SELECTIVE STREP AGAR W/5% SHEEP BLOOD (SSA¿); CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Catalog Number	221780
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	09/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H4.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use with the bd bbl¿ group a selective strep agar w/5% sheep blood (ssa¿), false results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: customer reports defective plate of 221780 causing test result incorrect.
Additional Manufacturer Narrative
Investigation summary during manufacturing of material 221780, media is formulated and sent through a high temperature short time sterilizer to remove bioburden.The petri dishes are subjected to uv radiation to decrease bioburden.The petri dishes are filled in a positive pressure hepa filtered environment.The filled plates are cooled and immediately wrapped into sleeves to decrease the introduction of microbes.Sleeves are then packaged into cartons and then transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the distributor.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media of 2 to 8 degrees c in a dark place.The release testing that is performed on this product does include physical attribute testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.They are tested for physical attributes prior to release to ensure that they conform to product specifications.All batches are tested prior to release and results reported on the certificate of analysis which can be obtained at www.Bd.Com/regdocs.Group a selective strep agar with 5% sheep blood is stability tested biennially for biological performance to ensure satisfactory performance throughout shelf life with the organisms that are reported on the certificate of analysis.No batch number, returns or photos were provided for investigation.Trending was done on the appropriate data bases for material 221780 and no history could be found for performance issues or physical plate defects from qc testing in the last 12 months.The complaint history was reviewed for material 221780 and there are no other complaints for performance defects in the last 12 months.Bd will continue to trend for defects.This complaint cannot be confirmed.
Event or Problem Description
It was reported that during use with the bd bbl¿ group a selective strep agar w/5% sheep blood (ssa¿), false results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: customer reports defective plate of 221780 causing test result incorrect.

• Brand Name: BD BBL¿ GROUP A SELECTIVE STREP AGAR W/5% SHEEP BLOOD (SSA¿)
• Common Device Name: CULTURE MEDIA, SELECTIVE AND 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 18024523
• Report Number: 1119779-2023-01189
• Device Sequence Number: 7759237
• Product Code: JSI
• UDI-Device Identifier: 30382902217801
• UDI-Public: (01)30382902217801
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K840294
• 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): 10/22/2024

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 Catalogue Number: 221780
• Device Lot Number: UNKNOWN
• 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: 09/29/2023
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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