MAUDE Adverse Event Report: 3M COMPANY 3M STEAM CHEMICAL INTEGRATOR TYPE 5; INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS

Model Number 1243

Device Problems Leak/Splash (1354); Explosion (4006)

Patient Problem Insufficient Information (4580)

Event Date 02/13/2023

Event Type  malfunction  

Event Description

The integrators explode and leak ink when sterilized.Lot #cr092025 and ex112025.

• Brand Name: 3M STEAM CHEMICAL INTEGRATOR TYPE 5
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 16435465
• MDR Text Key: 310251302
• Report Number: MW5115130
• 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: Patient
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1243
• Device Lot Number: EX112025
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1