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 of Device Ingredient or Reagent (2901)

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

Event Date 06/16/2022

Event Type  malfunction  

Event Description

It was reported that while using plate mueller hinton ii agar 20 ea the customer observed biological contamination in the form of mold present.This event occurred 1 time.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 media.".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, sparks has been listed in sections manufacturer name, city and state and manufacturer site, and the sparks fda registration number has been used for the manufacture report number.

Manufacturer Narrative

H.6 investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for foreign matter was observed.Additionally, retention samples from bd inventory were evaluated and foreign matter was not 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 foreign matter.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 the customer observed biological contamination in the form of mold present.This event occurred 1 time.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 media.".

• 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: 14982951
• MDR Text Key: 304360316
• Report Number: 1119779-2022-00982
• Device Sequence Number: 1
• Product Code: JTZ
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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