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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) plate was found contaminated.The following information was provided by the initial reporter: customer reports contamination and falling agar for this media 221261 lot 3179082.

Manufacturer Narrative

The following fields have been updated with additional information: d10.Device available for eval- yes.D10.Returned to manufacturer on: 08-aug-2023.H.6.Investigation summary: the batch history record for batch 3179082 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include physical attribute and bioburden testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.All physical attribute and 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 3179082.Retention samples from batch 3179082 were not available for inspection.Thirty plates from batch 3179082 were returned as three unopened sleeves shipped in a box with packing peanuts and air bubbles.Plates were inspected and 5/30 plates had surface bacterial growth and 6/30 plates had agar bed fallout (time stamps 0808 and 1225).One plate affected with growth was submitted to the id lab and pseudomonas fluorescens was identified.No photos were received for investigation.This complaint can be confirmed for agar bed fallout and contamination.Bd has identified a contamination trend for this product and the investigation found opportunities for bioburden reduction in the manufacturing process.A capa (corrective and preventative actions) has been initiated and involves implementing additional cleaning events and evaluation of manufacturing procedures focused on in-process bioburden reduction.Additional trainings are part of the implementation with an ongoing training review for cleaning processes.Improvement in observation of contamination is expected.Bd will continue to trend complaints for defects.

Event Description

It was reported that bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) plate was found contaminated.The following information was provided by the initial reporter: customer reports contamination and falling agar for this media 221261, lot 3179082.

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17647300
• MDR Text Key: 322269750
• Report Number: 1119779-2023-00956
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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: 10/24/2023
• Device Catalogue Number: 221261
• Device Lot Number: 3179082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1