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 Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

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 while using bd bbl trypticase soy agar with 5% sheep blood (tsa ii), there was contamination of 20 plates.No patient impact report.The following information was provided by the initial reporter: "customer reports contaminated media noticed before inoculation.Packages are sealed - no information about the colonies available.".

Manufacturer Narrative

The following fields have been updated with additional information: d10.Device available for eval- yes.D10.Returned to manufacturer on: 14-aug-2023.H.6.Investigation summary: the batch history record for batch 3152965 was satisfactory per internal procedures.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 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 3152965.Retention samples from batch 3152965 were not available for inspection.Twenty plates from batch 3152965 were returned as two unopened sleeves shipped in a box with paper padding.Plates were inspected and 2/20 plates had microbial growth (time stamps 1456 and 1504).Affected plate was submitted to the id lab and pseudomonas synxantha was identified.Five photos also were received for investigation.Three photos each show the top of an unopened sleeve with the plate print featured from batch 3152965 (time stamps 1456 and 1504).Two photos each show the side of a sleeve from batch 3152965 each with one plate that is darker in color that could be from contamination.This complaint can be confirmed for contamination by the photo provided.Due to the low defect rate (20 plates reported) for this batch; no actions are indicated at this time.Bd will continue to trend complaints for contamination.

Event Description

It was reported that while using bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii), there was contamination of 20 plates.No patient impact report.The following information was provided by the initial reporter: "customer reports contaminated media.Noticed before inoculation.Packages are sealed - no information about the colonies available.".

• 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: 17547476
• MDR Text Key: 321436644
• Report Number: 1119779-2023-00889
• 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: 09/27/2023
• Device Catalogue Number: 221261
• Device Lot Number: 3152965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• 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