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

Catalog Number 1243

Device Problems Leak/Splash (1354); Chemical Problem (2893)

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

Event Date 03/07/2023

Event Type  malfunction  

Event Description

Sterile processing department uses 3m chemical indicators, lot number ev122025.The chemical indicator bleeds red dye inside the peel pack pouch and some explode black dye.This was found during inspection and quality checks for peel pack pouches.

• Brand Name: 3M CHEMICAL INDICATORS
• Type of Device: INDICATOR, BIOLOGICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 16537279
• MDR Text Key: 311320225
• Report Number: MW5115725
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/10/2023

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 Catalogue Number: 1243
• Device Lot Number: EV122025
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2023
• Patient Sequence Number: 1