MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Model Number	221353
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	02/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 bd bbl¿ columbia cna agar with 5% sheep blood atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
Event or Problem Description
It was reported that while using bd bbl¿ columbia cna agar with 5% sheep blood atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
Additional Manufacturer Narrative
H6: investigation summary during manufacturing of material 221353, 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 0338818 was satisfactory at time of release and no quality notifications were generated during manufacturing and inspection.All batches are tested prior to release and results reported on the certificate of analysis which can be obtained at www.Bd.Com/regdocs.Columbia cna 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.All performance testing on this batch was satisfactory at the time of release.The complaint history was reviewed, and no other complaints have been taken on batch 0338818.Retention samples from batch 0338818 were not available for inspection.Three photos were received for investigation.--one photo shows the agar surface of three opened plates with growth along streak lines: two blood containing media and one macconkey ii agar plate (batch 0329377).The customer describes the inoculum on the three plates is the same.The amount of growth on all three plates is similar and the growth on the macconkey ii agar identifies the organism as a gram negative.If the inoculum on the three plates is the same and one of the blood containing media is a plate from batch 0338818, the reasoning is understood that there was no inhibition of the gram negative organism.--one photo shows the agar surface of three opened, streaked plates: two blood containing media plates with growth and one macconkey ii agar plate (batch 0345629) without growth.The customer describes the inoculum on the three plates is the same.--one photo shows the agar surface of two, opened streaked blood containing agar plates.The customer describes the inoculum on the two plates is the same.The amount of growth of both plates is heavy.Conclusions about performance cannot be made from photos of plates.Additionally, no verification of batch 0338818 can be made from the photos.No return samples were received for investigation.This complaint cannot be confirmed for a performance defect.Bd will continue to trend complaints for performance.H3 other text : see h10.

• Brand Name: BD BBL COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD
• Common Device Name: CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11427281
• Report Number: 1119779-2021-00436
• Device Sequence Number: 16838018
• Product Code: JSJ
• UDI-Device Identifier: 10382902213533
• UDI-Public: 10382902213533
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 03/01/2021
• Device Model Number: 221353
• Device Catalogue Number: 221353
• Device Lot Number: 0338818
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1