MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® SN BLOOD CULTURE BOTTLE

Catalog Number	259790
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 notified biomerieux of delayed results due to contamination associated with bact/alert® sn blood culture bottle (reference 259790).The customer reported seven (7) patients samples that with bacillus contamination in the blood culture bottles.Due to the contamination there was a delay in reporting patient results between 0.5 to 3.5 days.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.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated for a customer report of delayed results due to contamination associated with bact/alert® sn blood culture bottle (reference 259790).The customer reported seven (7) patient samples with bacillus contamination in the blood culture bottles.During the investigation, the customer performed an internal investigation at the site.On 21-mar-2019 biomérieux was notified that the contamination occurred at the customer site.The customer has retrained the staff on proper handling of the bact/alert bottles.The bottle instructions for use direct the bottle stopper to be disinfected prior to use.After removal of the plastic flip cap, use of one isopropyl alcohol disinfectant wipe per bottle type, allowed to air dry, provides satisfactory disinfection for the bottle stopper top.Complaint trending performed during our investigation did not reveal any issues with bact/alert bottle types or lots.Since the customer did not provide lot numbers for the inoculated contaminated bottles, no manufacturing records could be reviewed.However, at this time biomérieux is not aware of any issues internally in manufacturing for increased bacillus species contamination in any uninoculated bottles.

• Brand Name: BACT/ALERT® SN BLOOD CULTURE BOTTLE
• Common Device Name: BACT/ALERT® SN BLOOD CULTURE BOTTLE
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 7939932
• Report Number: 3002769706-2018-00198
• Device Sequence Number: 2269536
• Product Code: MDB
• UDI-Device Identifier: 03573026055813
• UDI-Public: 03573026055813
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K021123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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 Catalogue Number: 259790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2018
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR