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

Catalog Number	259790
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
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 biomérieux of a bacillus contamination association with the bact/alert® sn culture bottle (ref.259790, lot 0001055178) testing patient blood culture.The bacillus contamination was observed at two separate hospitals.The customer stated the blood culture was performed by both phlebotomists and nursing staff.The customer also confirmed the time to detection occurred after twenty-four (24) hours of incubation.The customer also observed bacillus contamination using the bact/alert® pf plus culture bottle (ref.410853, lot 0004055448).Refer to (b)(4).Biomérieux customer service requested detail regarding the blood culture collection procedure used, venipuncture sites, storage conditions of the bact/alert® pf plus culture bottles prior to use, and if any bottles appeared contaminated prior to use.Feedback has not yet been provided.There is no indication or report from the laboratory that the contamination result led to any adverse event related to any patient's state of health.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding a bacillus contamination in association with the bact/alert® sn culture bottle (ref.259790, lot: 0001055178) when testing patient blood culture.The bacillus contamination was observed at two separate hospitals.The impact of this event was low risk.Customers are instructed within the information for use (ifu) for the bact/alert® reagent to perform confirmatory tests on all positive bottles.Bacillus is known to be a common blood culture contaminant, per published literature.Based on the evaluation of data and limited information provided by the customer, the most probable root cause for contamination of the bottle from bact/alert® sn / lot: (b)(6) is human error (bottle handling) by the customer.Prior to inoculation, the culture bottle top needs to be disinfected with an alcohol swab or equivalent and allowed to dry.In addition, care must be taken to prevent contamination of a venipuncture during inoculation into the culture bottles (e.G.Proper skin disinfection).Cumitech 1c 4 for the proper specimen collection techniques (referenced in the ifus) also stresses that the disinfection of the venipuncture site is very important in order to reduce contamination.Contamination could lead to a specimen being determined positive when a clinically relevant isolate (e.G.Microbial organism) is not actually present.This situation occurred with the customer¿s sample resulting in a false positive by the contaminant of bacillus (environmental contaminant most often found in soil and water).There was no evidence of any bottle malfunctions with the bact/alert® sn / lot: (b)(6) within production lot records.Monitoring and detection methods for potential bottle contamination are part of the manufacturing and quality control processes for bact/alert® culture bottles.Bioburden results for bact/alert® sn / lot: (b)(6) were within the cfu/ml specification per release procedures.Therefore, there is no indication that the manufacturing processes for bact/alert® sn / lot: (b)(6) contributed to the contamination issue as per the complaint by the customer.

• Brand Name: BACT/ALERT SN (PLASTIC)
• Common Device Name: BACT/ALERT® SN (PLASTIC)
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 10510034
• Report Number: 3002769706-2020-00011
• Device Sequence Number: 16892284
• Product Code: MDB
• UDI-Device Identifier: 03573026055813
• UDI-Public: 03573026055813
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/12/2021

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: 02/03/2021
• Device Catalogue Number: 259790
• Device Lot Number: 0001055178
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1