MAUDE Adverse Event Report: 3M COMPANY ATTEST; INDICATOR, BIOLOGICAL STERILIZATION PROCESS

Model Number ATTEST

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 11/07/2022

Event Type  Injury  

Event Description

Failed 3m steam integrator x several attempts with pre-vac sterilization.Does not respond to sterilization.Fda safety report id# (b)(4).

• Brand Name: ATTEST
• Type of Device: INDICATOR, BIOLOGICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 15771073
• MDR Text Key: 303587038
• Report Number: MW5113207
• Device Sequence Number: 1
• Product Code: JOJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/07/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATTEST
• Device Catalogue Number: 1243A
• Device Lot Number: SF062025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3M STEAM CHEMICAL INTEGRATOR
• Patient Outcome(s): Required Intervention
• Patient Ethnicity: Non Hispanic