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

Catalog Number	221180
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
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 one bd bbl¿ sabouraud dextrose agar (deep fill) plate was contaminated prior to use.No patients were involved.The following information was provided by the initial reporter: a single plate in qc microbiology lab was discovered to have mold growth inside a newly opened sterile sleeve.Qa analyst observed mold growth on top of the agar of one sda (sabouraud dextrose agar).It was identified while performing bioburden testing.
Event or Problem Description
It was reported that one bd bbl¿ sabouraud dextrose agar (deep fill) plate was contaminated prior to use.No patients were involved.The following information was provided by the initial reporter: a single plate in qc microbiology lab was discovered to have mold growth inside a newly opened sterile sleeve.Qa analyst observed mold growth on top of the agar of one sda (sabouraud dextrose agar).It was identified while performing bioburden testing.
Additional Manufacturer Narrative
H.6: complaint investigation: during manufacturing of material 221180, 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 1343357 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 product and its packaging does not have any sterile claims.The complaint history was reviewed, and no other complaints have been taken on batch 1343357.Retention samples from batch 1343357 were not available for inspection.Three photos were received for investigation.One photo shows the side of a sleeve from with one plate highlighted with what appears to be microbial growth in the plate.The other two photos each show a plate from batch 1343357 (time stamp 1428) with fungal growth.No return samples were received for investigation of this complaint.This complaint can be confirmed by the photos provided.This product does not have a sterile claim.No complaint trends for contamination in this product have been identified; no actions are indicated at this time.Bd will continue to trend complaints for contamination.Risk management file review assessed the potential risk for the defect as severity s1 per baltrmppmgenpuraph, rev 02, id 6.13.

• Brand Name: BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL)
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14648117
• Report Number: 1119779-2022-00843
• Device Sequence Number: 17673756
• Product Code: JSI
• UDI-Device Identifier: 00382902211808
• UDI-Public: 00382902211808
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/20/2022

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: 05/09/2022
• Device Catalogue Number: 221180
• Device Lot Number: 1343357
• 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: 05/13/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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