MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) SEE H.10; 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 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device brand name: bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (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 prior to use with 4 bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ fungal contamination was discovered.

Event Description

It was reported that prior to use with 4 bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ fungal contamination was discovered.

Manufacturer Narrative

H.6.Investigation: 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 batches 0324225 were satisfactory at time of release 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 the only other complaints taken on batch 0324225 were also taken from this customer for contamination and other defects.Retention samples from batch 0324225 were not available for inspection.Two photos were received for investigation.One photo shows the bottom of a taped plate from batch 0324225 (time stamp 1259) with a fungal colony in the chromagar orientation medium.The other photo shows the bottom of four taped plates from batch 0324225 (time stamps 1207, 1208 and 1259) with at least one microbial colony visible at least one medium of each plate.No return samples were received for this complaint.This complaint can be confirmed for contamination.Bd will continue to trend complaints for contamination.Due to the number of complaints taken for contamination for material 222239, capa#3076308 has been initiated to determine the root cause and corrective actions of the contamination.

• Brand Name: SEE H.10
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11542718
• MDR Text Key: 242244668
• Report Number: 1119779-2021-00519
• Device Sequence Number: 1
• Product Code: JSH
• UDI-Device Identifier: 10382902222399
• UDI-Public: 10382902222399
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/22/2021
• Device Model Number: 222239
• Device Catalogue Number: 222239
• Device Lot Number: 0324225
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1