MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR; SEE H.10

Model Number 221734

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

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

Event Date 12/20/2022

Event Type  malfunction  

Event Description

It was reported that while using the bd bbl¿ cdc anaerobe 5% sheep blood agar that there was contamination.The following information was provided by the initial reporter: customer is reporting regarding item #221734 lot# 2291461 due to growth of cons, bacillus and s.Aureus.Customer is inquiring if bd has received any similar complaints on this lot.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Common device name: culture media, non-selective and non-differential.

Event Description

It was reported that while using the bd bbl¿ cdc anaerobe 5% sheep blood agar that there was contamination.The following information was provided by the initial reporter: customer is reporting regarding item #221734 lot# 2291461 due to growth of cons, bacillus and s.Aureus.Customer is inquiring if bd has received any similar complaints on this lot.

Manufacturer Narrative

H6 investigation summary: during manufacturing of material 221734, 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 review for batch 2291461 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 2291461.No retention samples for this batch were available for investigation.No photos were received for investigation.No return samples were received for investigation of this complaint.Bd has identified a contamination trend for this product and the investigation found opportunities for bioburden reduction in the manufacturing process.Additional trainings are planned with an ongoing training review for cleaning processes.

• Brand Name: BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16057189
• MDR Text Key: 306837178
• Report Number: 1119779-2022-01550
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K803025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

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: 02/01/2023
• Device Model Number: 221734
• Device Catalogue Number: 221734
• Device Lot Number: 2291461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• 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