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

Catalog Number 1243

Device Problems Fluid/Blood Leak (1250); Contamination /Decontamination Problem (2895)

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

Event Date 02/22/2023

Event Type  malfunction  

Event Description

3m steam sterilization integrator (chemical process indicator) reference#1243 leaking contents into sterilization pouch or container; contaminating surgical instruments and lot # packaging lot # ex11205 and lot # eg11205.Note- vha sent out notice on 02/17/2023 to be aware of potential issues and practice heightened awareness during qa checks of sterilization processes.Reference report: mw5115196.

• Brand Name: 3M ATTEST STEAM INTEGRATOR
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 16443644
• MDR Text Key: 310515967
• Report Number: MW5115197
• 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: 02/22/2023

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 Catalogue Number: 1243
• Device Lot Number: EG11205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other