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

Catalog Number 410852

Device Problems False Positive Result (1227); Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Event Description

Product description: bact/alert® fn plus culture bottles are used with bact/alert® microbial detection systems in qualitative procedures for the recovery and detection of anaerobic and facultative anaerobic microorganisms from blood and other normally sterile body fluids.Complaint description: a customer in the united states complained after having observed what they discribed as potential contamination when testing blood cultures from a patient's sample using bact/alert fn plus (plastic) (ref (b)(4) lot 0004058502, expiration date 08-apr-2023) in conjunction with their virtuo® system.The customer said that they had inoculated a blood sample from one patient into two bact/alert fn plus (plastic) bottles (nr0rxy4x and nr0s3pfk), and that after incubation these bottles were flagged as "positive".The customer mentioned that they had proceeded with smear and subculture of the positive bottles, and that they had confirmed the presence of clostridium perfringens using vitek ms technique.There is no indication or report from the customer that this event led to or contributed to a death, serious injury, or serious deterioration in the state of health of the concerned patient.The customer reported that they had observed the same issue when testing a blood culture from a different patient's sample using their alternative lot of bact/alert fn plus (plastic).This event has been recorded under (b)(4).

Manufacturer Narrative

Following the potential contamination with clostridium perfringens reported by the customer when using bact/alert® fn plus (bta) bottle (ref 410852 lot 0004058502) an investigation has been carried out at biomérieux manufacturing site.An historical review of last year¿s data found no other similar complaints for contamination in bact/alert® fn plus culture bottles reference 410852 and lot 0004058502.A review of manufacturing batch record of bact/alert® fn plus lot 0004058502 used by the customer was performed and no non-conformance or deviations were identified.The results of all in-process and quality assurance release for sales test were found to be within specification.Visual examination was performed on retained bottle lot 0004058502 by the investigator and all bottles had a slightly cloudiness appearance in the media, therefore further testing was done that confirmed the absence of microbial contamination.The cloudiness from bottle lot 0004058502 was thought to be resin fines or excess adhesion promoter.These two bottle defects are manufacturing process defects and has no impact to the fit or function of the finished product.No general product failure has been identified.In response to the contaminant of clostridium perfringens at the customer¿s site, the infection control department was contacted but an internal investigation was not performed.The customer stated there is construction in the area, but the demolition phase has been completed for over a year and the walls and ceiling were up during this timeframe.However, there was no mention of disinfection processes for areas where bottles typically have contact e.G., storage units for bottles, computer stations, phlebotomist carts.These areas could be sources of potential contamination.Conclusion: biomeriéux¿s investigation to date has been unable to identify a definitive root cause of the contamination observed by the customer.However it could not be ruled out that the contaminant entered the bottle with the sample, or that the patient sample did have the organism present from an unknown source.

• Brand Name: BACT/ALERT FN PLUS (PLASTIC)
• Type of Device: BACT/ALERT® FN 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: stefania ciranda ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16032404
• MDR Text Key: 308542080
• Report Number: 3002769706-2022-00053
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121455
• 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,Followup
• Report Date: 04/26/2023

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: 03/01/2023
• Device Catalogue Number: 410852
• Device Lot Number: 0004058502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 04/26/2023
• 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