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

Model Number 1243RE

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 06/17/2021

Event Type  malfunction  

Event Description

3m attest chemical steam integrator with extender used in surgical instrument kit failed to deploy ink.The ink releases to show that the surgical tray hit sterile parameters.Integrator appears to have malfunctioned.Four integrators from the same lot number all have ink that appears to be blown out the back.All product from lot is quarantined.Manufacturer notified.

• Brand Name: 3M ATTEST
• Type of Device: 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: 12058658
• MDR Text Key: 258107475
• Report Number: 12058658
• Device Sequence Number: 1
• Product Code: JOJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/18/2021

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: No Information
• Device Model Number: 1243RE
• Device Catalogue Number: 1243RE
• Device Lot Number: NY032023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2021
• Date Report to Manufacturer: 06/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1