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 had contacted biomérieux to report bacillus contamination associated with a bact/alert® fa plus culture bottles.An internal biomérieux investigation was performed.Bact/alert fa [plastic]- manufacturing direction (b)(4).A for release lot 1048103 was reviewed.The review included the quality control release testing and inspections, and all results were within specification.The bact/alert fa ifu 9311986 d 2016-03 has sufficient information regarding contamination: chemical or physical indications of instability prior to use, the bact/alert fa culture bottles should be examined for evidence of damage or deterioration (discoloration).Bottles exhibiting evidence of damage, leakage, or deterioration should be discarded.The media in undisturbed bottles should be clear, but there may be a slight opalescence or a trace of precipitate due to the anticoagulant sps.Do not confuse opalescence with turbidity.Do not use a bottle which contains media exhibiting turbidity, a yellow sensor, or excess gas pressure; these are signs of possible contamination.Specimen collection and preparation note: take care to prevent contamination during both bottle preparation and inoculation of the patient sample.Proper skin disinfection is an essential requirement to reduce the incidence of contamination.Direct draw inoculation procedure a contaminated culture bottle could contain positive pressure, and if used for direct draw, may cause reflux into the patient's vein.Culture bottle contamination may not be readily apparent.Monitor the direct draw process closely to avoid reflux.Do not use a bottle that contains media exhibiting turbidity, a yellow sensor, or excess gas pressure; these are signs of possible contamination.Procedural notes and precautions 1.Great care must be taken to prevent contamination of the patient sample during venipuncture and during inoculation into the culture bottle since contamination could lead to a specimen being determined positive when a clinically relevant isolate is not actually present.Biomérieux had previously investigated inoculated bottle contamination with bacillus.During the course of the investigation, there were no issues identified to suspect contamination was introduced in the bottles during the production process.There was no evidence of an event occurring during the manufacturing process that would have led to the contamination observed at the customer site.There was no evidence of a systemic issue with bact/alert® bottles, nor was it believed to be an issue with the manufacturing process itself.As a result, there were 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.

• 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: 6949944
• Report Number: 3002769706-2017-00299
• Device Sequence Number: 505902
• 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): 02/27/2018

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: 12/16/2017
• Device Catalogue Number: 259791
• Device Lot Number: 1048103
• 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: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1