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

Model Number 1243RE

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907); Packaging Problem (3007)

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

Event Date 03/11/2022

Event Type  malfunction  

Event Description

Two months ago we noted on our 3m steam chemical integrator (ci) strips where the extender was not attached to glue section & glue could stick to our surgical instruments.3m was involved straight away with their response to the issue and we have a letter of involvement since we informed them two months ago.Now after two months (from the first observation of this issue) we have seen more issues arising from the ci ref# 1243r (the cis we typically get has the extender).But in these cis, we see that the extender is not attached to the glue section.The glue could stick to our surgical instruments inside the tray, which could be a patient safety issue.The other two indicators are, issues with the move forward bead, again.The middle one has no white sheet and only the metal backing, with the bead exposed as well and not seated correctly.In the bottom device, a piece of the white sheet is not seated properly and we see that the piece is sticking behind the window.Without the white sheet, one will not be able to see the bead move into the acceptance range.In this month, they (cis) are all from the same lot #ta032024.This lot is what we have stocked on our workstations and in our warehouse inventory.We have directed our staff to check each ci prior to placing them in the sets and verify the bead is present, the white strip is present, the glue is not exposed and the bead is seated in the correct position.Note: our warehouse in supply chain has removed the current lot (ta032024) from the shelf.No patient harms.Our sterile processing manager continues to be in communication with 3m.Manufacturer response for steam chemical integrator, 3m steam chemical integrator (per site reporter).3m has been working with our sterile processing department from the onset and we have a letter of involvement.In this month we saw another recurrence and have been in contact again with 3m.

• Brand Name: 3M¿ ATTEST¿
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY; 3m center bldg 270-5n-01; st paul MN 55101 9924
• MDR Report Key: 14601311
• MDR Text Key: 293344852
• Report Number: 14601311
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1243RE
• Device Catalogue Number: 1243RE
• Device Lot Number: TA032024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1