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

Model Number 1295

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2017

Event Type  malfunction  

Event Description

Sterrad low temperature sterilizer and 2 other sterilizers were used - initially, it was thought that the actual sterilizers were not functioning properly.When run in the sterrad low temperature sterilizer (we tested in 2 different machines), we had the biologicals come back positive.Tested and ran different batches of bi's and it came out fine.We tested the old and new lot # of bi's and it was consistent, there is something wrong with this lot#.Pulled lot from use and put new lot in machine.Eliminated autoclave, so then it must be biologic or incubator.3m rep said it is a user error and that we either didn't get the medium cracked well enough or things were too tightly packed.This is not the case based on the amount of items listed on the sterilization record.I did perform a recall on all items sterilized on the loads with the positive bis as a precaution.We re-educated staff.We put the sterilizer back into service and the bundle failed.The deduction then is that the biologic is what is defective.

• Brand Name: ATTEST
• Type of Device: INDICATOR, BIOLOGICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY; 1617 north front st.; new ulm MN 56073
• MDR Report Key: 6857734
• MDR Text Key: 85800968
• Report Number: 6857734
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2017,08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2019
• Device Model Number: 1295
• Device Catalogue Number: 1295
• Device Lot Number: 2019-03NJ
• Other Device ID Number: (10)2019-03NJ
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: STERRAD LOW TEMPERATURE STERILIZER