MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // CHOCOLATE II AGAR; CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

Catalog Number 251416

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

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

Event Date 02/25/2022

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.

Event Description

It was reported that the bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) // chocolate ii agar was contaminated with bacterial growth before use.There was no report of adverse user or patient impact.The following information was provided by the initial reporter, translated from (b)(6): "this is a report about contamination of the media.According to the customer's report, bacterial growth was found in the media before usage.".

Event Description

It was reported that the bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) // chocolate ii agar was contaminated with bacterial growth before use.There was no report of adverse user or patient impact.The following information was provided by the initial reporter, translated from japanese: "this is a report about contamination of the media.According to the customer's report, bacterial growth was found in the media before usage.".

Manufacturer Narrative

Investigation summary the defect was not confirmed because there is no picture and returned sample.Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // CHOCOLATE II AGAR
• Type of Device: CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13841045
• MDR Text Key: 287589035
• Report Number: 1119779-2022-00454
• Device Sequence Number: 1
• Product Code: JTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/23/2022
• Device Catalogue Number: 251416
• Device Lot Number: 1300728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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