MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL CHOCOLATE II AGAR; CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

Model Number 221267

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that prior to use with bd bbl¿ chocolate ii agar the identifying labels were missing.

Manufacturer Narrative

H6: investigation summary: during manufacturing of material 221267, 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 0289979 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 0289979.Retention samples from batch 0289979 were not available for inspection.No return samples or photos were received for investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for labeling.

Event Description

It was reported that prior to use with bd bbl¿ chocolate ii agar the identifying labels were missing.

• Brand Name: BD BBL CHOCOLATE II AGAR
• Type of Device: CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11382243
• MDR Text Key: 245786425
• Report Number: 1119779-2021-00396
• Device Sequence Number: 1
• Product Code: JTY
• UDI-Device Identifier: 10382902212673
• UDI-Public: 10382902212673
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/08/2021
• Device Model Number: 221267
• Device Catalogue Number: 221267
• Device Lot Number: 0289979
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1