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 Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2021

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 while using bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) the plates had poor or no growth.This occurred on qc and patient samples.12 cases were affected, the patient impact was not reported.

Event Description

It was reported while using bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) the plates had poor or no growth.This occurred on qc and patient samples.12 cases were affected, the patient impact was not reported.

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval?: yes.Returned to manufacturer on: 1/5/2021 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 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 0296788 was satisfactory at time of release and no quality notifications were generated during manufacturing and inspection.All batches are tested prior to release and results reported on the certificate of analysis (coa) which can be obtained at www.Bd.Com/regdocs.Trypticase soy agar with 5% sheep blood is stability tested biennially for biological performance to ensure satisfactory performance throughout shelf life with the organisms that are reported on the certificate of analysis.All performance testing on this batch was satisfactory at the time of release.The complaint history was reviewed, and no other complaints have been taken on batch 0296788.Retention samples from batch 0296788 were not available for inspection.Three photos were received for investigation.One photo shows the bottom of a plate from batch 0296788 (time stamp 0717) with the plate print featured for batch verification.Another photo shows a plate from batch 0296788 (time stamp 0717) held up.The agar is still opaque and light red.The third photo shows the bottom of a plate from batch 0296788 (time stamp 0717) with light red agar and a plate of product from a competitor.The plates from batch 0296788 shown in the photos are within the color specification of bright, light to medium red.Twenty plates from batch 0296788 also were returned as two unopened sleeves shipped in a box with air bubbles and plastic bag padding (time stamps 0718 and 0719).All returned plates were within the color specification of bright, light to medium red.For investigation, returned plates were performance tested per the standard performance protocol for material 221261 as described in the coa.All organisms tested had satisfactory growth per procedure.Return testing did now show any performance defects.This complaint cannot be confirmed.Bd will continue to trend complaints for performance.

• 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: 11223070
• MDR Text Key: 228438803
• Report Number: 1119779-2021-00133
• 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: 08/27/2021

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: 02/10/2021
• Device Catalogue Number: 221261
• Device Lot Number: 0296788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1