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 Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

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.

Event Description

It was reported that 2 plates of bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) were discovered to be contaminated prior to inoculation.The following information was provided by the initial reporter: it was reported that there is contamination.

Event Description

It was reported that 2 plates of bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) were discovered to be contaminated prior to inoculation.The following information was provided by the initial reporter: it was reported that there is contamination.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-08-02 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 1161409 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 1161409.Retention samples from batch 1161409 were not available for inspection.Four photos were received for investigation.Two photos each show the bottom of a plate from batch 1161409 (time stamp 2346) with the plate print featured for batch verification.Another photo shows the bottom of a sleeve with bacterial colonies growing on the agar surface of the bottom plate visible.The last photo shows the agar surface of an opened plate with a large bacterial colony.Ten plates from batch 1161409 also were returned as one unopened sleeve shipped in a box with bubble wrap.Plates were inspected and 1/10 returned plates had surface bacterial growth (time stamp 2345).The affected plate was submitted to the id lab and pseudomonas fluorescens was identified.This complaint can be confirmed.A trend was identified for contamination and investigation found opportunities for bioburden reduction in the manufacturing process.A capa (corrective and preventative actions) 3076308 has been initiated and involves implementing additional cleaning events and evaluation of manufacturing procedures focused on in-process bioburden reduction.See h10.

• 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
• 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: 12339881
• MDR Text Key: 267348304
• Report Number: 1119779-2021-01405
• Device Sequence Number: 1
• Product Code: JTY
• UDI-Device Identifier: 10382902212673
• UDI-Public: 10382902212673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

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
• Device Operator: Other
• Device Expiration Date: 10/04/2021
• Device Model Number: 221267
• Device Catalogue Number: 221267
• Device Lot Number: 1161409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1