MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR); CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number	221283
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	10/13/2021
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¿ trypticase¿ soy agar (soybean-casein digest agar) mold was discovered growing on 7 plates.The following information was provided by the initial reporter: distributor reported contamination of fungus or mold growing on the plates on customer's behalf.These were not opened as the contamination growth can be seen through the plastic wrapping.
Event or Problem Description
It was reported that prior to use with bd bbl¿ trypticase¿ soy agar (soybean-casein digest agar) mold was discovered growing on 7 plates.The following information was provided by the initial reporter: distributor reported contamination of fungus or mold growing on the plates on customer's behalf.These were not opened as the contamination growth can be seen through the plastic wrapping.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-21.H6: investigation summary during manufacturing of material 221283, 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 1195815 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 1195815 for contamination.Retention samples from batch 1195815 were not available for inspection.Fifty plates from batch 1195815 were returned as five unopened sleeves shipped in a box with air bubbles (time stamps 2233, 2248, 2252 and 0448).Plates were inspected, and 42/50 returned plates had surface fungal growth.Two affected plates were submitted to the id lab and the observed fungal growth was found to be non-viable.It is noted that there were maggots found in 11/50 plates from two of the returned sleeves.Five photos also were received for investigation.One photo shows the top of an opened carton fungal growth visible in the top plates of at least six of the sleeves from batch 1195815 (time stamp 2248).Three photos each show the top of two opened cartons from batch 1195815 (time stamps 2241, 2244, 2247, 2248, 2250, 0447,and 0448) with fungal growth visible in some of the top plates visible.One photo shows seven opened cartons from batch 1195815 (carton 0466, 0473, 0752) with microbial growth visible in some top plates of the sleeves.Mold was observed in the returns but was found to be not viable.The presence of maggots in the returns without mention of them by the customer could indicate they were introduced in the return shipment process.This complaint has been confirmed.No complaint trends for contamination have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for contamination.H3 other text : see h10.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12788607
• Report Number: 1119779-2021-01797
• Device Sequence Number: 20079267
• Product Code: JSG
• UDI-Device Identifier: 10382902212833
• UDI-Public: 10382902212833
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 03/09/2022

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: 11/08/2021
• Device Model Number: 221283
• Device Catalogue Number: 221283
• Device Lot Number: 1195815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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