MAUDE Adverse Event Report: ITL BIOMEDICAL SAFETY SUBCULTURE UNIT 2 (SCU2); DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC

Model Number A100722

Device Problems Contamination (1120); Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Event Description

Summary of alleged event: the customer reported that when using the safety subculture unit 2 (scu2) product (reference (b)(4), serial (b)(6)) with the bact/alert bottle, the blood sample can sometimes spurt out, contaminating the environment.The customer confirmed that there was no instance in which the technicians using the scu2 with the bact/alert bottle were harmed.No technician was exposed to the blood samples.The reporting customer confirmed that the technician was not adversely impacted by the blood splatter.The customer received the safety subculture unit 2 from biomerieux, as a distributor of itl biomedical.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SAFETY SUBCULTURE UNIT 2 (SCU2)
• Type of Device: DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC
• Manufacturer (Section D): ITL BIOMEDICAL
• MDR Report Key: 17534864
• MDR Text Key: 321415812
• Report Number: MW5141763
• Device Sequence Number: 1
• Product Code: LIB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2020

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?: No
• Device Model Number: A100722
• Device Lot Number: 806CM6068
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1