MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL CHOCOLATE II AGAR, 100 PLATES; CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

Catalog Number 251267

Device Problem Contamination (1120)

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

Event Date 06/20/2023

Event Type  malfunction  

Event Description

It was reported that while using bd bbl chocolate ii agar, 100 plates there was contamination found on the media.Thirty plates were affected.There was no patient impact.The following information was provided by the initial reporter: "according to the customer's report, signs of whitish matter were found on the surface of the media.".

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.

Manufacturer Narrative

The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes, d9: returned to manufacturer on: 2023-07-11.H.6.Investigation summary: material #: 251267; lot/batch #: 3101725.Bd received customer returned samples and photos for investigation.The photos were reviewed and the indicated failure mode for biological contamination with the incident lot was not observed.Additionally, the customer samples along with retention samples from bd inventory, were evaluated and no issues were identified.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for contamination.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported that while using bd bbl chocolate ii agar, 100 plates there was contamination found on the media.Thirty plates were affected.There was no patient impact.The following information was provided by the initial reporter: "according to the customer's report, signs of whitish matter were found on the surface of the media.".

• Brand Name: BD BBL CHOCOLATE II AGAR, 100 PLATES
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17299033
• MDR Text Key: 319699924
• Report Number: 1119779-2023-00760
• 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: 07/13/2023

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: 08/07/2023
• Device Catalogue Number: 251267
• Device Lot Number: 3101725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1