MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MODIFIED THAYER-MARTIN (MTM II) AGAR; CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

Model Number	221568
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that no label information was seen in ten bd bbl¿ modified thayer-martin (mtm ii) agar.The following information was provided by the initial reporter: no product name, expiration date and lot number on plate.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that no label information was seen in ten bd bbl¿ modified thayer-martin (mtm ii) agar.The following information was provided by the initial reporter: no product name, expiration date and lot number on plate.
Additional Manufacturer Narrative
H.6.Investigation summary: during manufacturing of material 221568, 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 3020955 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.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.They 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 3020955.Three photos were received for investigation of this complaint.The first photo shows several plates, one with batch number 3020955 (time stamp 1007) can be seen while the other plates in the photo have missing or illegible plate prints.The second photo shows a stack of plates from batch 3020955 (time stamps not visible).The third photo shows a plate with an illegible plate print.No return samples were received for investigation of this complaint.No retention samples were available for investigation of this complaint.This complaint can be confirmed.No complaint trends for this defect have been identified; no actions are indicated at this time.Bd will continue to trend complaints for missing and illegible plate print.

• Brand Name: BD BBL¿ MODIFIED THAYER-MARTIN (MTM II) AGAR
• Common Device Name: CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17087357
• Report Number: 1119779-2023-00626
• Device Sequence Number: 2723764
• Product Code: JTY
• UDI-Device Identifier: 10382902215681
• UDI-Public: 10382902215681
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K760588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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: 05/15/2023
• Device Model Number: 221568
• Device Catalogue Number: 221568
• Device Lot Number: 3020955
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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