MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PLATE BI COL CNA SB & COL CNA SB 100 EA; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Model Number	299818
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	04/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using a plate bi col cna sb & col cna sb 100 ea mold 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: "damaged¿mildew¿agar uneven surface.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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
H6: investigation summary: during manufacturing of material 299818, 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 batch history record for batch 1063379 was satisfactory and no quality notifications were generated during manufacturing and inspection.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 physical attribute testing performed on this batch was satisfactory per bd internal procedures.The complaint history was reviewed, and no other complaints have been taken on batch 1063379.Retention samples from batch 1063379 were not available for inspection.Seven photos were received for investigation.--one photo shows the side of a plate from batch 1063379 (time stamp 0600) with a cracked lid.--one photo shows the bottom of eight plates from batch 1063379 (time stamp 0600) that are broken.--one photo shows the side of a bi-plate with a cracked lid.--one photo shows an opened plate with a broken lid.--one photo shows the bottom of a plate from batch 1063379 with microbial growth in one bi-plate half visible.--one photo shows the bottom of a plate from batch 1063379 with what appears to have bubbles in agar of one bi-plate half.--one photo shows the agar surface of a bi-plate with bubbles in the media of one half.No return samples were received for investigation.This complaint has been confirmed.Based on the low defect rate for this batch, no actions are planned at this time.Bd will continue to trend complaints for these defects.H3 other text : see h10.
Event or Problem Description
It was reported that while using a plate bi col cna sb & col cna sb 100 ea mold 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: "damaged mildew agar uneven surface.".

• Brand Name: PLATE BI COL CNA SB & COL CNA SB 100 EA
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11877705
• Report Number: 1119779-2021-00885
• Device Sequence Number: 3305348
• Product Code: JSI
• UDI-Device Identifier: 10382902998188
• UDI-Public: 10382902998188
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• 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): 10/20/2021

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: 05/31/2021
• Device Model Number: 299818
• Device Catalogue Number: 299818
• Device Lot Number: 1063379
• 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: 04/28/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• 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