MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR (TSA II)-I PLATE; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Model Number 222239

Device Problem Contamination (1120)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1050222.Medical device expiration date: 2021-05-20.Device manufacture date: 2021-02-19.Medical device lot #: 1028433.Medical device expiration date: 2021-04-30.Device manufacture date: 2021-01-28.Medical device lot #: 1057953.Medical device expiration date: 2021-05-28.Device manufacture date: 2021-02-26.

Event Description

It was reported that while using 10 bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar (tsa ii)-i plate¿ fungal and bacterial contamination were observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that contamination.Customer problem: chrom orient plates 222239 lots contamination 1050222, 1028433, 1057953.Chrom orient 1050222, fungal 1 plate.Chrom orient 1028433, bacterial 2 plates.Chrom orient 1057953, bacterial 7 plates.".

Manufacturer Narrative

H6: 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 records for batches 1050222, 1028433 and 1057953 were satisfactory at time of release and no quality notifications were generated during manufacturing or inspection of these batches.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 these batches were 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 for contamination were taken on batches 1028433 and 1057953.No other complaints have been taken on batch 1050222.Retention samples from batches 1050222, 1028433, and 1057953 were not available for inspection.Four photos were received for investigation.--one photo shows the bottom of a plate from batch 1028433 (time stamp 1038) with microbial growth in the tsa with 5% sheep blood medium.--one photo shows the bottom of a plate from batch 1050222 (time stamp 1632) with microbial growth in the chromagar orientation medium.--one photo shows the bottom of a plate from batch 1057953 (time stamp 0144) with microbial growth in the tsa with 5% sb medium.--one photo shows a stack of plates from batch 1057953 (time stamp 0144) with microbial growth in tsa with 5% sb of the top plate.No return samples were received for investigation.This complaint can be confirmed.Bd will continue to trend complaints for contamination.Due to the number of complaints taken for contamination for material 222239, a capa (corrective and preventative actions) 3076308 has been initiated to determine the root cause and corrective actions of the contamination.

Event Description

It was reported that while using 10 bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar (tsa ii)-i plate¿ fungal and bacterial contamination were observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that contamination: ¿ customer problem: chrom orient plates 222239 lots contamination 1050222, 1028433, 1057953.Chrom orient 1050222 fungal 1 plate.Chrom orient 1028433 bacterial 2 plates.Chrom orient 1057953 bacterial 7 plates.".

• Brand Name: BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR (TSA II)-I PLATE
• 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: 11807057
• MDR Text Key: 268271769
• Report Number: 1119779-2021-00794
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 222239
• Device Catalogue Number: 222239
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1