MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II); CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number 221239

Device Problem Microbial Contamination of Device (2303)

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

Event Date 04/14/2021

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 that prior to use with bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) fungal contamination was discovered on plate.The following information was provided by the initial reporter: customer reporting fungal contamination on 221239 plates lot 1042195.

Manufacturer Narrative

H.6.Investigation: during manufacturing of material 221239, 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 review for batch 1042195 was satisfactory at time of release per internal procedures.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 1042195.Retention samples from batch 1042195 were not available for inspection.No return samples or photos were received for investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for contamination.H3 other text : see h.10.

Event Description

It was reported that prior to use with bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) fungal contamination was discovered on plate.The following information was provided by the initial reporter: customer reporting fungal contamination on 221239 plates lot 1042195.

• Brand Name: BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11780749
• MDR Text Key: 278183956
• Report Number: 1119779-2021-00768
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 10382902212390
• UDI-Public: 10382902212390
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/02/2021
• Device Model Number: 221239
• Device Catalogue Number: 221239
• Device Lot Number: 1042195
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1