MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT FA PLUS (PLASTIC) ®

Catalog Number 410851

Device Problem Microbial Contamination of Device (2303)

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

Event Type  malfunction  

Event Description

Intended use: bact/alert® fa plus culture bottles are used with bact/alert® microbial detection systems in qualitative procedures for recovery and detection of aerobic and facultative anaerobic (bacteria and yeast) from blood and other normally sterilebody fluids.Description of the issue: a customer in the united states notified biomérieux of experiencing a potential bottle contamination with paecilomyces variotii when using the bact/alert fa plus (plastic) - 410851 (lot# 004101558, expiration date : 2/15/2024).Customer has reported three (3) fa+ bottles with mold.They obtained an identification of paecilomyces variotii for two bottles and will be checking the third bottle later.Plates all looked the same macroscopically as well.One bottle was requested to be sent out for identification so far (has not come back yet).All bottles were collected at the same hospital, customer is in the process of doing their own investigation.As the time of the assessment, the identification of the third bottle is unknown.There is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.An investigation has been initiated.

• Brand Name: BACT/ALERT FA PLUS (PLASTIC) ®
• Type of Device: BACT/ALERT FA PLUS (PLASTIC) ®
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• Manufacturer (Section G): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• Manufacturer Contact: céline lacroix gimon ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 17098960
• MDR Text Key: 316883320
• Report Number: 3002769706-2023-00018
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026357900
• UDI-Public: 03573026357900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2023

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: Health Professional
• Device Expiration Date: 02/15/2024
• Device Catalogue Number: 410851
• Device Lot Number: 0004101558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1