MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ HEKTOEN ENTERIC AGAR; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Catalog Number	221365
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	05/24/2021
Type of Reportable Event	Malfunction
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 while using bd bbl¿ hektoen enteric agar 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: " it was reported that contamination.".
Additional Manufacturer Narrative
H.6.Investigation: during manufacturing of material 221365, 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 1099191 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 other complaints have been taken on batch 1099191 for contamination from other customers.Retention samples from batch 1099191 were not available for inspection.Two photos were received for investigation.One photo shows a packaging slip with two cartons of batch 1099191 as one of the line items for batch verification.The other photo shows the agar surface of two plates from batch 1099191 (time stamp 1307); one of the plates in the photo has many bacteria colonies growing on the surface.No return samples were received for investigation.This complaint can be confirmed.A trend was identified for contamination and investigation found opportunities for bioburden reduction in the manufacturing process.Capa#3076308 has been initiated and involves implementing additional cleaning events and evaluation of manufacturing procedures focused on in-process bioburden reduction.Additional trainings are planned with an ongoing training review for cleaning processes.Bd will continue to trend complaints for contamination.H3 other text : see h.10.
Event or Problem Description
It was reported that while using bd bbl¿ hektoen enteric agar 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: " it was reported that contamination.".

• Brand Name: BD BBL¿ HEKTOEN ENTERIC AGAR
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12028650
• Report Number: 1119779-2021-01014
• Device Sequence Number: 4543825
• Product Code: JSI
• UDI-Device Identifier: 00382902213659
• UDI-Public: 00382902213659
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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: 07/08/2021
• Device Catalogue Number: 221365
• Device Lot Number: 1099191
• 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: 05/24/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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