MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® SN 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 biomérieux of recovering bacillus species when testing with bact/alert® sa bottles (lots 1052576, 1053278 and 1053002), bact/alert sn bottles (lots 1053350, 1052950 and 1053162) and bact/alert fa bottles (lot 1053482).The customer reported that the suspected contamination of bacillus was obtained for multiple patients.The customer stated there was no delay in reporting results.The customer reported the physician suspected the results were contamination.No patient was treated for bacillus.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in the united states notified biomérieux of recovering bacillus species when testing with bact/alert® sa bottles (lots 1052576, 1053278 and 1053002), bact/alert sn bottles (lots 1053350, 1052950 and 1053162) and bact/alert fa bottles (lot 1053482).In response to the customer complaint, biomérieux conducted an internal investigation.The investigation included a review of manufacturing records and a review of the instructions for use (ifu).No evidence was found in the manufacturing record review to show a problem with contamination of bottles.The batch met all release criteria and quality assurance subsequently released the lots for distribution to the field.Evaluation of complaints showed no adverse trend is present in the complaint data for inoculated bottle contamination involving the following organisms: bacillus, paenibacillus, and staphylococcus.The review of the bottle ifu found the ifu contains sufficient directions for cleaning the bottle stopper, and avoidance of contaminating the bottle during inoculation.There is no evidence found at the time of this investigation, that the source for this customer's complaint is contamination of the bottle by the manufacturer prior to use by the customer.The most likely root cause is contamination at the time of inoculation.

• Brand Name: BACT/ALERT® SN CULTURE BOTTLE
• Common Device Name: BACT/ALERT® SN CULTURE BOTTLE
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 8864498
• Report Number: 3002769706-2019-00028
• Device Sequence Number: 19521594
• 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): 03/19/2020

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: 02/22/2020
• Device Catalogue Number: 259790
• Device Lot Number: 1053162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1