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

Model Number 221267

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2021

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 while using the bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) contamination was observed prior to use.The following information was provided by the initial reporter: it was reported that the customer observed microbial growth outside of the streaking area after incubation of inoculated chocolate ii agar plates from lot 0267381 (item 221267).

Manufacturer Narrative

H.6.Investigation: 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 0267381 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 0267381.Retention samples from batch 0267381 were not available for inspection.No returns or photos were received for investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for contamination.

Event Description

It was reported that while using the bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) contamination was observed prior to use the following information was provided by the initial reporter: it was reported that the customer observed microbial growth outside of the streaking area after incubation of inoculated chocolate ii agar plates from lot 0267381 (item 221267).

• Brand Name: BD BBL CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX)
• 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: 11135341
• MDR Text Key: 228214324
• Report Number: 1119779-2021-00040
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/19/2021
• Device Model Number: 221267
• Device Catalogue Number: 221267
• Device Lot Number: 0267381
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1