MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PLATE MUELLER HINTON II AGAR 20 EA; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH

Catalog Number 251177

Device Problem Contamination (1120)

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

Event Date 06/08/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 plate mueller hinton ii agar 20 ea biological contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "this is a report about contamination of the media.According to the customer's report, mold was found on the agar.".

Manufacturer Narrative

H.6 investigation summary: material #: 251177.Lot/batch #: 2088793.Bd received customer] samples and photos for investigation.The photos were reviewed and the indicated failure mode for contamination was observed.Additionally, the customer samples along with retention samples from bd inventory, were evaluated.Contamination was observed in customer returns.No issues found in retention samples.Device history record review was conducted.There was a stuck dish issue.No other issues noted.This complaint has been confirmed for contamination based on the photo and customer returns provided.No complaint trend.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 while using plate mueller hinton ii agar 20 ea biological contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "this is a report about contamination of the media.According to the customer's report, mold was found on the agar.".

• Brand Name: PLATE MUELLER HINTON II AGAR 20 EA
• Type of Device: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH
• 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: 14739425
• MDR Text Key: 302838557
• Report Number: 1119779-2022-00913
• Device Sequence Number: 1
• Product Code: JTZ
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/25/2022
• Device Catalogue Number: 251177
• Device Lot Number: 2088793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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