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	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use 3 bd bbl¿ (b)(6) cna agar with (b)(6) sheep blood media plates were contaminated with bacteria.There was no report of patient impact.The following information was provided by the initial reporter: contamination is bacterial, and is under/in the agar.Customer stated 2 plates were found to be contaminated.Organism not id¿d.Plates appear to be hemolyzed.
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 prior to use 3 bd bbl¿ columbia cna agar with 5% sheep blood media plates were contaminated with bacteria.There was no report of patient impact.The following information was provided by the initial reporter: contamination is bacterial, and is under/in the agar.Customer stated 2 plates were found to be contaminated.Organism not id¿d.Plates appear to be hemolyzed.
Additional Manufacturer Narrative
H.6 investigation summary: this memo is to summarize findings regarding the complaint related to catalog number 221353, plate columbia cna agar 5% sb 100 ea, for batch number 1246413 and complaint number (b)(4) for contamination.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 1246413 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include bioburden testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.All bioburden testing performed on this batch was satisfactory per bd internal procedures.Affected product does not have any sterility claims; the product is tested for bioburden prior to release to ensure that it conforms to product specifications.However, this does not ensure that the end-user will not receive a contaminated plate.The complaint history was reviewed, and no other complaints have been taken on batch 1246413.Retention samples from batch 1246413 were not available for inspection.Ten plates from batch 1246413 were returned as one unopened sleeve in a zip lock bags shipped in a box with return samples for another batch.Plates were inspected and 0/10 plates had microbial growth (time stamps 0026 and 0027).One of the returned plates did have hemolysis of the media.Three photos also were received for investigation.One photo shows the bottom of a plate from batch 1246413 (time stamp 0028) with what appears to be hemolysis of the media.Another photo shows the agar surface of a plate with hemolyzed media.The last photo shows the top of a sleeve with what appears to be hemolyzed media in the top plate.Hemolysis of the media can be caused by microbial growth, but indication of microbial growth was observed in the returns and photos.This complaint can be confirmed for hemolysis.No complaint trends for hemolysis has been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for hemolysis.

• 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
• 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: 12804735
• Report Number: 1119779-2021-01810
• Device Sequence Number: 4698930
• Product Code: JSJ
• UDI-Device Identifier: 10382902213533
• UDI-Public: 10382902213533
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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: 12/01/2021
• Device Model Number: 221353
• Device Catalogue Number: 221353
• Device Lot Number: 1246413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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