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

Catalog Number	254093
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bbl¿ chromagar¿ candida, there was a false result due to contamination.There was no report of patient impact.
Additional Manufacturer Narrative
E1.Initial reporter address: (b)(6).Investigation summary: during manufacturing of material 254093, 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 main component of prepared plated media is purified water.The purified water is held in an agar matrix in the media.Release of the purified water as the matrix contracts during temperature cycling and progression through shelf life is referred to as exudation.As media progresses through shelf life, some condensate will appear inside the sleeves, dishes or on the agar surface.This condensate or excessive moisture occasionally presents upon removal from storage and packaging.Plates can be inverted over the lid and allowed to dry before inoculation when condensate/excessive moisture is noted.It is best to do this 2 to 3 hours directly before inoculating the plates (see warnings and precautions section of the product insert where applicable).Control of the temperature cycling that bd product experiences may help reduce the amount of free moisture seen.Pooling of water inside the sleeve is not considered a normal amount of excessive moisture.If this is observed, please contact technical services and document the occurrence with photographs as soon as possible after it is noticed.The batch history record for batch 4179184 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 4179184.Retention samples from batch 4179184 were not available for inspection.Seven photos were received for investigation.--one photo shows the agar surface of a plate from batch 4179184 (time stamp 1647) with a colony of growth on the agar surface.--three photos each show the agar surface of a plate from batch 4179187 (time stamp 1647) with one or two morphologies of growth on the agar surface one of which appears fungal.--two photos each show the agar surface of plate with large fungal colonies.Excessive moisture was not observed in the photos received for investigation.No return samples were received for investigation.This complaint cannot be confirmed for excessive moisture.This complaint can be confirmed for contamination.No complaint trend for contamination has been identified for this product; no actions are indicated at this time per bd procedures.Bd will continue to trend complaints for defects.This mdr is being submitted as part of a retrospective review of records dating april 2023¿2025, under capa 11910483.

• Brand Name: BD BBL¿ CHROMAGAR¿ CANDIDA
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22948619
• Report Number: 1119779-2025-04835
• Device Sequence Number: 9893903
• Product Code: JSI
• UDI-Device Identifier: 10382902540936
• UDI-Public: (01)10382902540936(11)240627(17)241001(10)4179184
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: 10/01/2024
• Device Catalogue Number: 254093
• Device Lot Number: 4179184
• 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: 10/14/2024
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2024
• 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