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

Catalog Number	259791
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states contacted biomérieux to report bacillus contamination associated with a bact/alert® fa plus culture bottles.The culture bottle provided a positive result within one day after sample collection.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in the united states contacted biomérieux to report bacillus contamination associated with a bact/alert® fa plus culture bottles.The culture bottle provided a positive result within one day after sample collection.An internal biomérieux investigation was performed.During the course of the investigation, there were no issues identified to suspect contamination was introduced in the bottles during the production process of bact/alert® fa plus bottle.There is no evidence of an event occurring during the manufacturing process that would have led to the contamination observed at the customer site.This is the only report of inoculated bottle contamination with bacillus pumilus during the period reviewed for this investigation.There is no evidence of a systemic issue with bact/alert® bottles, nor is it believed to be an issue with the manufacturing process itself.As a result, there are no new proposed corrective and/or preventive actions from this investigation.There were no other products, process, or systems impacted as a result of this investigation.No follow-up information had been provided by the customer on their investigation on the collection devices as possible sources of contamination.The customer did not indicate any impact to patients due to this issue.

• Brand Name: BACT/ALERT® FA PLUS
• Common Device Name: BACT/ALERT® FA PLUS
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 6949814
• Report Number: 3002769706-2017-00298
• Device Sequence Number: 1112061
• Product Code: MDB
• UDI-Device Identifier: 03573026055820
• UDI-Public: 03573026055820
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K121461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2017
• Device Catalogue Number: 259791
• Device Lot Number: 1048011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1