MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR (100 SHELF PACK); CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Model Number 215081

Device Problem Contamination (1120)

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

Event Date 01/08/2022

Event Type  malfunction  

Event Description

It was reported that the plates were contaminated with bd bbl¿ chromagar¿ orientation agar (100 shelf pack).The following information was provided by the initial reporter: it was reported that the chromagar orientation plates are contaminated.

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 the plates were contaminated with bd bbl¿ chromagar¿ orientation agar (100 shelf pack).The following information was provided by the initial reporter: it was reported that the chromagar orientation plates are contaminated.

Manufacturer Narrative

H.6 investigation summary: complaint investigation.During manufacturing of material 215081, 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 1294578 was satisfactory and no quality notifications were generated during manufacturing and inspection of either batch.The release testing that is performed on this product does include physical attribute and bioburden testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.All physical attribute and 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 complaints from other customers have been taken for batch 1294578 for agar defects but no other complaints have been taken for contamination.Retention samples from batch 1294578 were not available for inspection.Six photos were received for investigation.--three photos each show the bottom of a plate from batch 1294578 (time stamps 1252 and 1253) with an air bubble between the agar bed and plate bottom.--one photo shows the bottom of a plate from batch 1294578 (time stamp 1246) with a colony of growth.--one photo shows the bottom of a plate from batch 1294578 (time stamp 1252) with the agar bed fallen out of the plate bottom.--one photo shows the profile of a plate with the agar bed sitting in the plate lid rather than the plate bottom.No return samples were received for investigation.Air bubbles between the agar bed and plate bottom indicate agar bed fallout.Uneven agar was not observed in the photos.This complaint cannot be confirmed for uneven agar.This complaint can be confirmed for agar bed fallout and contamination.A trend was identified for contamination and investigation found opportunities for bioburden reduction in the manufacturing process.Additional trainings are planned with an ongoing training review for cleaning processes.Bd will continue to trend complaints for contamination and agar defects.Risk management file review assessed the potential risk for the defect as severity 1 per baltrmppmgenpuraph, rev 02, id 6.13.

• Brand Name: BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR (100 SHELF PACK)
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL
• 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: 13359542
• MDR Text Key: 288869251
• Report Number: 1119779-2022-00122
• Device Sequence Number: 1
• Product Code: JSH
• UDI-Device Identifier: 10382902150814
• UDI-Public: 10382902150814
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/15/2022
• Device Model Number: 215081
• Device Catalogue Number: 215081
• Device Lot Number: 1294578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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