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

Event Date 01/29/2021

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 during use with bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) unusual beta hemolysis for enterococcus species has been observed.There was no report of patient impact.

Manufacturer Narrative

The following fields have been updated with corrected information: d.4.Medical device lot #: 0338919 d.4.Medical device expiration date: 2021-03-26 h.4.Device manufacture date: 2020-12-03.

Event Description

It was reported during use with bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) unusual beta hemolysis for enterococcus species has been observed.There was no report of patient impact.

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 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 0338919 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 which can be obtained at www.Bd.Com/regdocs.Trypticase soy agar with 5% sheep blood is stability tested annually 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 0338919.Retention samples from batch 0338919 were not available for inspection.One photo was received for investigation.The photo shows a close up of the bottom of a plate from batch 0338919 (time stamp 0408) with markings on the bottom of the plate and red-brown agar.The complaint describes atypical hemolysis when enterococcus species is grown.While the media does appear hemolyzed in the photo, no conclusions about that observation can be made from the photo.Conclusions about performance cannot be determined from photos.No returns were received for investigation.This complaint cannot be confirmed for a performance defect.Bd will continue to trend complaints for performance.

Event Description

It was reported during use with bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) unusual beta hemolysis for enterococcus species has been observed.There was no report of patient impact.

• 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: 11353656
• MDR Text Key: 243744116
• Report Number: 1119779-2021-00336
• 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,Followup
• Report Date: 09/04/2021

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: 03/26/2021
• Device Catalogue Number: 221261
• Device Lot Number: 0338919
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 02/24/2021; 09/04/2021
• Supplement Dates FDA Received: 02/25/2021; 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1