MAUDE Adverse Event Report: BIOMÉRIEUX INC. VITEK 2 0.45% SODIUM CHLORIDE DILUENT

Catalog Number	417820
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
Intended use: saline solution is a diluent used for manual preparation of organism suspensions, prior to identification and antimicrobial susceptibility processing with vitek® 2 instruments.The vitek 2 0.45% sodium chloride diluent - 417820 is not manufactured by biomérieux.This item is a third-party product manufactured by pisa.Issue description: a customer in austria notified biomérieux of user harm related to vitek 2 0.45% sodium chloride diluent (ref.417820, lot q2410028 , exp date 01-april-2026).User was injured while modifying a new vitek 2 0.45% sodium chloride diluent to be placed in the vitek 2 xl as the mounting hole was too small to fit onto the mounting pin in side the instrument.The user attempted to enlarge the hole with scissors.During this scissors use, user was injured; she obtained a finger laceration which needed to be sutured and underwent treatment.User is unable to work for three weeks.Note: the product, vitek 2 0.45% sodium chloride diluent - 417820, did not directly cause the injury.The use of scissors by the customer to modify the saline bag was the cause of the injury.Customer also indicated that the user manual states that the saline bag hole needs to be placed on the pin inside the instrument to place the bag correctly.As this was not possible without excess force and manipulation, customer used the scissors to enlarge the hole to be able to put the bag hole on the pin.Biomérieux global industry customer service stated that as there is no mention in any of biomérieux official documentation to use scissors, and after analysis of video provided by the customer, the user should have requested help rather than using scissors to install the bag.The use of scissors is considered to be off-label use and user error.In alignment with biomérieux (b)(4), biomérieux vigilance operational team (vot) requested the biomérieux third party products (tpp) team to notify pisa of this issue due to the claim of an injury.Note: pisa is a cmo (contract manufacturing organization) for the saline bag, and the bag is acquired by pisa through a supplier (pympsa).

• Brand Name: VITEK 2 0.45% SODIUM CHLORIDE DILUENT
• Common Device Name: VITEK 2 0.45% SODIUM CHLORIDE DILUENT
• Manufacturer (Section D): BIOMÉRIEUX INC.; 595 anglum rd.; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum rd.; hazelwood MO
• Manufacturer Contact: céline lacroix-gimon ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 24326644
• Report Number: 1950204-2026-00001
• Device Sequence Number: 9966609
• Product Code: LON
• UDI-Device Identifier: 03573026463533
• UDI-Public: 03573026463533
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: N50510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Catalogue Number: 417820
• Device Lot Number: Q2410028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown