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

Model Number TYPE 5

Device Problems Contamination /Decontamination Problem (2895); Material Integrity Problem (2978)

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

Event Date 02/09/2023

Event Type  malfunction  

Event Description

3m type 5 indicators from the lot fe112025 began to show integrity issues.So far 10 indicators have been identified at our facility as having bled the dye out of the indicator and onto the packaging.Reference report #mw5115200, #mw5115201, #mw5115202, #mw5115203, #mw5115205, #mw5115206, #mw5115207, #mw5115208, #mw5115209.

• Brand Name: TYPE 5 STEAM CHEMICAL INDICATOR
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 16444037
• MDR Text Key: 310496122
• Report Number: MW5115204
• 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: Unknown
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TYPE 5
• Device Catalogue Number: 1243
• Device Lot Number: FE112025
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1