MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PLATE SHEEP BLOOD AGAR (T) 20 EA.; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Catalog Number 251148

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 06/23/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The manufacturing location for this product is fukushima.This site is not registered with the fda.Therefore sparks has been listed in sections and the sparks fda registration number has been used for the manufacture report number.

Event Description

It was reported that mold was found on plate sheep blood agar (t) 20 ea.The following information was provided by the initial reporter.The customer stated: this is a report about contamination of the media.According to the customer's report, mold was found on the media before usage.

Manufacturer Narrative

H6.Investigation summary: 251148-lot# 2088817 fungi we confirmed issue from returned sample.The issue was contamination of fungi.No trend.Root cause was undetermined.No issue in retention h3 other text : see h10.

Event Description

It was reported that mold was found on plate sheep blood agar (t) 20 ea.The following information was provided by the initial reporter.The customer stated: this is a report about contamination of the media.According to the customer's report, mold was found on the media before usage.

• Brand Name: PLATE SHEEP BLOOD AGAR (T) 20 EA.
• Type of Device: CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL
• 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: 15090398
• MDR Text Key: 303640627
• Report Number: 1119779-2022-01021
• Device Sequence Number: 1
• Product Code: JSI
• 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: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/28/2022
• Device Catalogue Number: 251148
• Device Lot Number: 2088817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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