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

Catalog Number 221261

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

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.(b)(4).

Event Description

It was reported that prior to use with bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) contamination of plates were discovered on 15 plates.

Manufacturer Narrative

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 0296736 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 our 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 typical levels.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 on this batch was taken from this customer for a different defect (pr (b)(4), surface defect).A total of five photos were received in lieu of returns for pr (b)(4) and pr (b)(4).For pr (b)(4), one photo shows the bottom of a plate from batch 0296736 (time stamp 2315) with the plate print featured and surface bacterial growth visible.Four photos for pr (b)(4) are similar and each show the agar surface of opened plates with at least one bacterial colony in each plate.Some plates picture also have few small bubbles in the agar surface.No other observations can be made from the photos.Bd will continue to trend complaints for contamination.This complaint can be confirmed by the photos provided.Review of shipping data for this batch found that this batch was distributed to multiple customers in the united states and the only complaints taken are from this customer.Bd acknowledges and confirms the defect recorded in this complaint but no further actions are required after complaint investigation per internal procedures.

Event Description

It was reported that prior to use with bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) contamination of plates were discovered on 15 plates.

• Brand Name: BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
• Type of Device: CULTURE MEDIA, NON-SELECTIVE & NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11297027
• MDR Text Key: 243420302
• Report Number: 1119779-2021-00269
• 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: 04/06/2021

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 Date: 02/08/2021
• Device Catalogue Number: 221261
• Device Lot Number: 0296736
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1