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

Catalog Number	221278
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 when using the bd bbl¿ sabouraud dextrose agar (deep fill) a plate was found without a label.No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: during manufacturing of material (b)(4), 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 review for batch 3178157 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include physical attribute testing.The products are tested for physical attributes prior to release to ensure that they conform to product specifications.All physical attribute testing performed on this batch was satisfactory per bd internal procedures.The complaint history was reviewed, and no other complaints have been taken on batch 3178157 for this defect.There were no retention samples available for investigation of this complaint.No photos, returns or retains were available for this investigation.This complaint cannot be confirmed.No photos or returns were presented.No complaint trends for this defect have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for these defects.
Event or Problem Description
It was reported when using the bd bbl¿ sabouraud dextrose agar (deep fill) a plate was found without a label.No health impact or consequence reported.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18243448
• Report Number: 1119779-2023-01294
• Device Sequence Number: 12423208
• Product Code: JSI
• UDI-Device Identifier: 30382902212783
• UDI-Public: (01)30382902212783
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/24/2024

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: 11/30/2023
• Device Catalogue Number: 221278
• Device Lot Number: 3178157
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2023
• 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