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U.S. Department of Health and Human Services

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
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BECTON, DICKINSON & CO. (SPARKS) BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II); CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL Back to Search Results
Catalog Number 221261
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2021
Event Type  malfunction  
Event Description
It was reported that prior to use with bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) 60 plates were discovered to be contaminated.The following information was provided by the initial reporter: it was reported that customer reporting contamination in media item 221261 lot 1028451 - plate trypticase soy agar 5% sb.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-04-14.H6: investigation summary: during manufacturing of material 221261, 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 1028451 was 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 no other complaints have been taken on batch 1028451 for contamination.Retention samples from batch 1028451 were not available for inspection.Return samples were received for investigation.Sixty plates from batch 1028451 were returned as six sleeves (five unopened, one opened) shipped in a box (time stamps 2312 and 2313).Plates were inspected and 32/60 plates had surface and subsurface microbial growth.Growth was submitted to the id lab and aerococcus viridans and pseudarthrobacter species were identified.Three photos also were received for investigation.One photo shows the surface of three plates with surface and/or subsurface growth visible in each plate.Another photo shows a close up of the side of a sleeve with at least five plates in the photo with microbial growth in the media.The last photo shows a copy of a sleeve label from batch 1028451 for batch verification.This complaint can be confirmed.Bd will continue to trend complaints for contamination.Based on the low defect rate for this batch, no actions are planned at this time.
 
Event Description
It was reported that prior to use with bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) 60 plates were discovered to be contaminated.The following information was provided by the initial reporter: it was reported that customer reporting contamination in media item 221261 lot 1028451 - plate trypticase soy agar 5% sb.
 
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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 Key11761761
MDR Text Key280710890
Report Number1119779-2021-00765
Device Sequence Number1
Product Code JSG
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 10/06/2021
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 Date05/21/2021
Device Catalogue Number221261
Device Lot Number1028451
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2021
Initial Date Manufacturer Received 04/07/2021
Initial Date FDA Received05/03/2021
Supplement Dates Manufacturer Received10/06/2021
Supplement Dates FDA Received10/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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