MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MACCONKEY II AGAR WITH SORBITOL; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Model Number	298519
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	10/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with bd bbl¿ macconkey ii agar with sorbitol 6 plates had subsurface growth.There was no report of patient impact.The following information was provided by the initial reporter: macconkey ii w/ sorbitol plates failed sterility qc.6 of 10 sterility plates had subsurface growth.
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 during use with bd bbl¿ macconkey ii agar with sorbitol 6 plates had subsurface growth.There was no report of patient impact.The following information was provided by the initial reporter: macconkey ii w/ sorbitol plates failed sterility qc.6 of 10 sterility plates had subsurface growth.
Additional Manufacturer Narrative
H.6 investigation summary: during manufacturing of material 298519, 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 1216762 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 1216762.Retention samples from batch 1216762 were not available for inspection.Eighty plates from batch 1216762 were returned as eight unopened sleeves shipped in a box.Prior to inspection, plates were incubated at 20 to 25 degrees c (4 sleeves) and 33 to 37 degrees c (4 sleeves).Plates were inspected at 3 days incubation and 0/80 plates had microbial growth (time stamps 0250-0252).No photos were received for investigation.A trend was identified for contamination and investigation found opportunities for bioburden reduction in the manufacturing process.A capa (corrective and preventative actions) has been initiated and involves implementing additional cleaning events and evaluation of manufacturing procedures focused on in-process bioburden reduction.Additional trainings are planned with an ongoing training review for cleaning processes.This complaint can be confirmed by the identified trend.Bd will continue to trend complaints for contamination.H3 other text : see h.10.

• Brand Name: BD BBL¿ MACCONKEY II AGAR WITH SORBITOL
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12774667
• Report Number: 1119779-2021-01781
• Device Sequence Number: 5207726
• Product Code: JSI
• UDI-Device Identifier: 10382902985195
• UDI-Public: 10382902985195
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K871855
• 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): 08/31/2022

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: 11/19/2021
• Device Model Number: 298519
• Device Catalogue Number: 298519
• Device Lot Number: 1216762
• 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: 10/11/2021
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• 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