MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH

Catalog Number 251801

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 07/07/2022

Event Type  malfunction  

Event Description

It was reported that while using bbl - mueller hinton agar with 5% sheep blood the customer noticed biological contamination.This event occurred 1 time.The following information was provided by the initial reporter: "the customer found foreign matter which could be bacteria in the media.".

Manufacturer Narrative

Date of event.The date received by manufacturer has been used for this field 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 fukushima, japan.This site is an oem manufacturing site.Therefore, sparks has been listed and the sparks fda registration number has been used for the manufacture report number.

Manufacturer Narrative

H.6.Investigation summary 251801 lot#2073206 contamination we confirmed the issue as a report from returned sample.The issue was contamination.No trend.We will continue to monitor this issue.

Event Description

It was reported that while using bbl - mueller hinton agar with 5% sheep blood the customer noticed biological contamination.This event occurred 1 time.The following information was provided by the initial reporter: "the customer found foreign matter which could be bacteria in the media.".

• Brand Name: BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
• 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: 15157969
• MDR Text Key: 305257311
• Report Number: 1119779-2022-01056
• 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: 08/31/2022

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: Health Professional
• Device Expiration Date: 07/12/2022
• Device Catalogue Number: 251801
• Device Lot Number: 2073206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 09/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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