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

Catalog Number 221261

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0247863, medical device expiration date: 2020-12-23, device manufacture date: 2020-09-03; medical device lot #: 0254250, medical device expiration date: 2020-12-31, device manufacture date: 2020-09-10; medical device lot #: 0267420, medical device expiration date: 2021-01-12, device manufacture date: 2020-09-23; medical device lot #: 0281173, medical device expiration date: 2021-01-29, device manufacture date: 2020-10-07.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that prior to use with bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) plates were discovered to be contaminated.Lot 0281173 - bacterial 5 plates; lot 0267420 - bacterial 5 plates, fungal 1 plate; lot 0247863 - bacterial 1 plate; lot 0254250 - bacterial 1 plate.

Event Description

It was reported that prior to use with bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) plates were discovered to be contaminated.Lot 0281173 - bacterial 5 plates lot 0267420 - bacterial 5 plates, fungal 1 plate lot 0247863 - bacterial 1 plate lot 0254250 - bacterial 1 plate.

Manufacturer Narrative

Investigation: 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 8o 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 0281173, 0267420, 0247863 and 0254250 were satisfactory at time of release and no quality notifications were generated during manufacturing and inspection for any of these batches.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 the batches in question 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 the only other complaint taken on batch 0247863 was from this customer for contamination on a different shipment (complaint 2082446).There are no other complaints taken on batches 0281173, 0267420 and 0254250.Retention samples from batches 0281173, 0267420, 0247863 and 0254250 were not available for inspection.Four photos were received in lieu of returns for investigation.One photo shows the bottom of a taped plate from batch 0254250 (time stamp 1713) with microbial growth visible.One photo shows the bottom of a taped plate from batch 0247863 (time stamp 1333) with microbial growth visible in the plate.Another photo shows a close up of the bottom of a taped plate from batch 0267420 (time stamp 1143) with microbial growth.The last photo shows the bottom of five taped plates with microbial growth in each plate.In this photo the plate prints cannot be read for batch verification.No verification of batch 0281173 can be made from the photos.This complaint can be confirmed contamination in batches 026740, 0247862 and 0245250 by the photos provided.This complaint cannot be confirmed for contamination in batch 0281173.It is noted that batch 0267420 expired on 2021-01-12, batch 0247863 expired on 2020-12-23 and batch 0254250 expired on 2020-12-30.This complaint was taken on january 28, 2021.Bd does not make claims on expired product and this product does not have a sterility claim.Bd will continue to trend complaints for contamination.Based on the low defect rate for both batches, no actions are planned at this time.Based on the low defect rate for the batches in question, no actions are planned at this time.

• 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: 11346178
• MDR Text Key: 232566049
• Report Number: 1119779-2021-00327
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• 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: 07/23/2021

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 Catalogue Number: 221261
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1