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

Model Number 222239

Device Problem Contamination (1120)

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

Event Date 03/04/2021

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 a plate of bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ was contaminated.The following information was provided by the initial reporter: it was reported that customer has one plate contaminated with 222239 plates.

Event Description

It was reported that a plate of bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ was contaminated.The following information was provided by the initial reporter: it was reported that customer has one plate contaminated with 222239 plates.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-03-08 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 record for batch 0365601 was satisfactory and no quality notifications were generated during manufacturing and inspection.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 one other complaint has been taken on batch 0365601 for contamination from another customer.It is noted that this customer does have another complaint on batch 0365601.Retention samples from batch 0365601 were not available for inspection.Returns were received for investigation.Twenty-two plates from batch 0365601 were turned as two unopened sleeves (20 plates) and 2 loose shipped in a box with foam padding (time stamps 0735, 0745 and 0906).Plates in the unopened sleeves were inspected and 5/20 plates had thin and uneven chromagar orientation agar beds and 0/20 plates had microbial growth.For investigation, some returned plates were divided and incubated at 20 to 25 degrees c (7 plates) and 33 to 37 degrees c (7 plates).No microbial growth was observed in the incubated plates at 3 days incubation.One of the loose plates had surface bacterial growth.Because the plate had been shipped as loose plates in a box, the growth observed was not identified.Three photos also were received for investigation.One photo shows the top of an unopened sleeve with what appears to be fungal growth on the chromagar orientation medium of the top plate.Another photo shows the sleeve label from batch 0365601 for batch verification.The last photo shows the side of an unopened sleeve with microbial growth on the chromagar orientation medium of the top plate.This complaint can be confirmed for low fill and contamination.Bd will continue to trend complaints for fill volume and contamination.Based on the low defect rate for this batch, no actions are planned at this time for fill volume.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.H3 other text : see h10.

• 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
• MDR Report Key: 12425187
• MDR Text Key: 275496129
• Report Number: 1119779-2021-01470
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/29/2021
• Device Model Number: 222239
• Device Catalogue Number: 222239
• Device Lot Number: 0365601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1