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

Model Number 1243A

Device Problem Material Discolored (1170)

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

Event Date 10/21/2021

Event Type  malfunction  

Event Description

No serious effects noted; our facility are users of the 3m attest steam chemical integrator.It was noted that the newest bath with a bright red and green color on the integrator are leaving a red/pinkish stain on our peel pack items.This creates a nonconformity for our product and deem them contaminated.Issue noted with lot pf062023, ref 1243a.Fda safety report id# (b)(4).

• Brand Name: STEAM CHEMICAL INTEGRATOR
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 12703862
• MDR Text Key: 279008891
• Report Number: MW5104962
• Device Sequence Number: 1
• Product Code: JOJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/28/2023
• Device Model Number: 1243A
• Device Catalogue Number: 1243A
• Device Lot Number: PF062023
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other