MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) SEE H10; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Model Number 222239

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

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

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device brand name: bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w (b)(6) (tsa ii)-i plate¿ 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 there were 20 bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w (b)(6) (tsa ii)-i plate¿ that were contaminated.There was no report of patient impact.The following information was provided by the initial reporter: (b)(6).

Manufacturer Narrative

H.6 investigation summary: during manufacturing of material 222239, 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 1216742 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 1216742.Retention samples from batch 1216742 were not available for inspection.One photo as received for investigation.The photo shows the bottom of five plates from batch 1216742 (time stamps 1014, 1034, 1036, 1051) with microbial growth visible in one medium of at least 3 plates.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.A capa (corrective and preventative actions) 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.

Event Description

It was reported that there were 20 bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ that were contaminated.There was no report of patient impact.The following information was provided by the initial reporter: pollution.

• Brand Name: SEE H10
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12816351
• MDR Text Key: 284884322
• Report Number: 1119779-2021-01816
• Device Sequence Number: 1
• Product Code: JSH
• UDI-Device Identifier: 10382902222399
• UDI-Public: 10382902222399
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/05/2021
• Device Model Number: 222239
• Device Catalogue Number: 222239
• Device Lot Number: 1216742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• 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