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

Catalog Number 410853

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in the united states contacted biomerieux to report bacillus non-anthracis contamination associated with bact/alert® fa plus culture bottles.The customer reported seeing an increase in contamination, a total of 26 blood culture bottles.Out of the 26 blood culture bottles there are 20 different patients.The customer stated that they noticed the issue in (b)(6) 2017, and the issue has been reoccurring since (b)(6)2017.The customer stated that the following lot numbers, the blood culture bottles grew bacillus spps non- anthracis: part number: 410851, lot# 3048950 fa plus {reference pr (b)(4) } part number: 410851, lot# 3049086 fa plus {reference pr (b)(4) } part number: 410852, lot# 3049078 fn plus {reference pr (b)(4) } part number: 410853, lot# unknown pf plus (customer is sure that they had a pf bottle that grew bacillus non-anthracis) {reference pr (b)(4) } the customer does not believe that any patients received antibiotic therapy as a result of the contamination.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in the united states had contacted biomérieux to report bacillus non-anthracis contamination associated with bact/alert® pf plus culture bottles, lot # unknown.An internal biomérieux was performed.The customer did not provide the pf plus bottle lot number involved.They did not provide enough information to evaluate the complaint further.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.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® PF PLUS
• Type of Device: BACT/ALERT® PF PLUS
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 7010801
• MDR Text Key: 92606874
• Report Number: 3002769706-2017-00346
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026357924
• UDI-Public: 03573026357924
• Combination Product (y/n): N
• PMA/PMN Number: K121446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 410853
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1