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

Model Number	1243RE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Sterile processing reported having intermittent issues with the 3m attest chemical integrators (lot # td122025, ref# (b)(4)) not passing their sets, with two of the same lot# in a set.One will pass and the other will not pass.Upon inspecting the indicators, it was noted that the ink cartridge from the one that doesn't pass is concaved, while the one that deployed ink appropriately doesn't look concave.3 sets have recently had this issue.Manufacturer response for indicator, physical/chemical sterilization process, 3m attest (per site reporter).The hospital's 3m rep was notified.No response received to date.

• Brand Name: 3M ATTEST
• Common Device Name: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave.; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 16875472
• Report Number: 16875472
• Device Sequence Number: 20648493
• Product Code: JOJ
• UDI-Device Identifier: 30707387785759
• UDI-Public: (01)30707387785759(17)251226(10)TD122025
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/28/2023
• Report Date (Section F): 04/28/2023

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 Model Number: 1243RE
• Device Catalogue Number: 1243RE
• Device Lot Number: TD122025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/28/2023