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

Catalog Number 251267

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

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

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

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 plate chocolate ii agar 100 ea mold found in media before usage.The following information was provided by the initial reporter: mold was found in the media before usage.

Manufacturer Narrative

H.6 investigation summary: 251267.#2327899.Bd had not received samples, but one (1) photo was provided for investigation.The photo was reviewed and the indicated failure mode for contamination was observed.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 has been confirmed for the indicated failure mode contamination.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that plate chocolate ii agar 100 ea mold found in media before usage.The following information was provided by the initial reporter: mold was found in the media before usage.

• Brand Name: PLATE CHOCOLATE II AGAR 100 EA
• 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: 16221936
• MDR Text Key: 308084757
• Report Number: 1119779-2023-00048
• Device Sequence Number: 1
• Product Code: JTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 01/24/2023

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: 03/21/2023
• Device Catalogue Number: 251267
• Device Lot Number: 2327899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2022
• 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