MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) SEE H.10

Model Number 221267

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

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

Event Date 02/11/2023

Event Type  malfunction  

Event Description

It was reported that bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) fungal growth was found.The following information was provided by the initial reporter: upon opening of the packaging of our 221267 bbl plated media, fungal growth is seen in the inside of the plate.

Manufacturer Narrative

Medical device brand name: bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) common device name: culture media, for isolation of pathogenic neisseria a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6.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 2305646 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 2305646 for soft agar.No retention samples for batch 2305646 were available for inspection.There were two photos received for investigation of this complaint.The first photo shows an opened sleeve of plates from batch 2305646.The second photo shows a plate from batch 2305646 with contamination on the agar surface (time stamp not visible).No return samples were available for investigation.This complaint can be confirmed for contamination.No complaint trends for this defect have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints defects.H3 other text : see h10.

Event Description

It was reported that bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) fungal growth was found.The following information was provided by the initial reporter: upon opening of the packaging of our 221267 bbl plated media, fungal growth is seen in the inside of the plate.

• Brand Name: SEE H.10
• Type of Device: SEE H.10
• 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: 16444991
• MDR Text Key: 310596328
• Report Number: 1119779-2023-00182
• Device Sequence Number: 1
• Product Code: JTY
• UDI-Device Identifier: 10382902212673
• UDI-Public: 10382902212673
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Model Number: 221267
• Device Catalogue Number: 221267
• Device Lot Number: 2305646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1