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

Model Number	221271
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	07/08/2022
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 while using bd bbl¿ mannitol salt agar that the product had the wrong ph right out of the box.The following information was provided by the initial reporter: "customer reports media 221271 with lot#:2125146 had the wrong ph right out of the box.Po#: (b)(6).Multiple attempts were made to contact the customer.".
Additional Manufacturer Narrative
H.6 investigation summary: during manufacturing of material 221271, 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 2125146 was satisfactory and no quality notifications were generated during manufacturing and inspection.All batches are tested prior to release and results reported on the certificate of analysis which can be obtained at www.Bd.Com/regdocs.Mannitol salt agar is stability tested biennially for biological performance to ensure satisfactory performance throughout shelf life with the organisms that are reported on the certificate of analysis.All performance testing on this batch was satisfactory at the time of release.The complaint history was reviewed, and no other complaints have been taken on batch 2125146.Retention samples from batch 2125146 were not available for inspection.This complaint cannot be confirmed.
Event or Problem Description
It was reported that while using bd bbl¿ mannitol salt agar that the product had the wrong ph right out of the box.The following information was provided by the initial reporter: "customer reports media 221271 with lot#:2125146 had the wrong ph right out of the box.Po#: (b)(6).Multiple attempts were made to contact the customer".

• Brand Name: BD BBL¿ MANNITOL SALT AGAR
• 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: 15188674
• Report Number: 1119779-2022-01084
• Device Sequence Number: 12154092
• Product Code: JSI
• UDI-Device Identifier: 10382902212710
• UDI-Public: 10382902212710
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/20/2023

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: 08/15/2022
• Device Model Number: 221271
• Device Catalogue Number: 221271
• Device Lot Number: 2125146
• 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: 07/11/2022
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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