MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MACCONKEY II AGAR; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Model Number 221270

Device Problem Contamination (1120)

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

Event Date 12/02/2021

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 when opening bd bbl¿ macconkey ii agar contamination was discovered.This occurred with 8 plates.The following information was provided by the initial reporter: it was reported by the customer that the plates have bacterial contamination upon opening.

Event Description

It was reported when opening bd bbl¿ macconkey ii agar contamination was discovered.This occurred with 8 plates.The following information was provided by the initial reporter: it was reported by the customer that the plates have bacterial contamination upon opening.

Manufacturer Narrative

H.6.Investigation: during manufacturing of material 221270, 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 1285612 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 other complaints have been taken for contamination of batch 1285612 including another from university hospital for a different incident date (complaint (b)(4) ).Retention samples from batch 1285612 were not available for inspection.Four photos were received for investigation.One photo shows a clsi checklist sheet from a shipment with 8 cartons of batch 1285612 listed.The other three photos each show a close up of the top of an unopened sleeve from batch 1285612 (time stamp 0736) with microbial growth visible in the top plate.No return samples were received for investigation.This complaint can be confirmed.A trend was identified for contamination and investigation found opportunities for bioburden reduction in the manufacturing process.Capa#3076308 has been initiated and involves implementing additional cleaning events and evaluation of manufacturing procedures focused on in-process bioburden reduction.Additional trainings are planned with an ongoing training review for cleaning processes.Bd will continue to trend complaints for contamination.H3 other text : see h.10.

• Brand Name: BD BBL¿ MACCONKEY II AGAR
• Type of Device: CULTURE MEDIA, 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: 13111778
• MDR Text Key: 284137196
• Report Number: 1119779-2021-02057
• Device Sequence Number: 1
• Product Code: JSI
• UDI-Device Identifier: 10382902212703
• UDI-Public: 10382902212703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/07/2022
• Device Model Number: 221270
• Device Catalogue Number: 221270
• Device Lot Number: 1285612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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