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

Model Number	221733
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that prior to use with bd bbl¿ cdc anaerobe 5% sheep blood agar the plates were discovered to be contaminated.The following information was provided by the initial reporter: it was reported that plate contamination occurred.Was media contamination noticed upon receiving or at a later time? later time.Upon receiving: who is the distributor and what temperature were the media shipped? cardinal; refrigerated.If at later time: what was the storage temperature of media? were sleeves sealed during storage? refrigerated and yes.Any recent temperature excursions? no.Was contamination noticed before or after inoculation? before.If after inoculation, were any patient results reported? no.Visual inspection: bacteria or fungi contamination ¿ colony color? white predominately, some green and peachy orange.Location of contamination ¿ surface or sub-surface? surface.Were the organism gram stained or identified? no.What is the time stamp on the plates? lot 1035483.0622/2021/05/17.Are the products available to return? if so, are the sleeves sealed? sleeves are not sealed at this time, available for return.
Event or Problem Description
It was reported that prior to use with bd bbl¿ cdc anaerobe 5% sheep blood agar the plates were discovered to be contaminated.The following information was provided by the initial reporter: it was reported that plate contamination occurred.Was media contamination noticed upon receiving or at a later time? later time upon receiving: who is the distributor and what temperature were the media shipped? cardinal refrigerated.If at later time: what was the storage temperature of media? were sleeves sealed during storage? refrigerated and yes.Any recent temperature excursions? no.Was contamination noticed before or after inoculation? before if after inoculation, were any patient results reported? no.Visual inspection.Bacteria or fungi contamination ¿ colony color? white predominately, some green and peachy orange.Location of contamination ¿ surface or sub-surface surface.Were the organism gram stained or identified? no.What is the time stamp on the plates?lot 1035483 0622/2021/05/17.Are the products available to return? if so, are the sleeves sealed? sleeves are not sealed at this time, available for return.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 5/10/2021.H.6.Investigation: during manufacturing of material 221733, 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 1035483 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 1035483.Retention samples from batch 1035483 were not available for inspection.One plate from batch 1035483 was returned as a loose plate in a ziplock bag shipped in a fedex overpak envelope (time stamp 0622).The returned plate had surface bacterial growth that was sent to the id lab.Pseudomonas fluorescens was identified in the return sample.No photos 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 contamination.H3 other text : see h.10.

• Brand Name: BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR
• Common Device Name: CULTURE MEDIA, NON-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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11860007
• Report Number: 1119779-2021-00877
• Device Sequence Number: 17136837
• Product Code: JSG
• UDI-Device Identifier: 10382902217333
• UDI-Public: 10382902217333
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K803025
• 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): 11/02/2021

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: 05/17/2021
• Device Model Number: 221733
• Device Catalogue Number: 221733
• Device Lot Number: 1035483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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