MAUDE Adverse Event Report: 3M COMPANY 3M CHEMICAL INTEGRATOR; INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS

Model Number 1243

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

Class 5 chemical integrator did not turn after exposure to steam sterilization.All others on the same load did turn.Fda safety report id# (b)(4).

• Brand Name: 3M CHEMICAL INTEGRATOR
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY; st. paul MN 55144
• MDR Report Key: 12751025
• MDR Text Key: 280451508
• Report Number: MW5105120
• 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: 11/01/2021

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
• Device Operator: Health Professional
• Device Model Number: 1243
• Device Lot Number: LY072023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1