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

Model Number 1243

Device Problems Material Discolored (1170); Fluid/Blood Leak (1250)

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

Event Date 02/23/2023

Event Type  malfunction  

Event Description

Sterilized a peel pack and noticed a black substance inside the peel pack.With further investigation sps noticed that the 3m steam chemical integrators leaked ref #1243, lot #ct112025.

• Brand Name: 3M CHEMICAL INTEGRATOR
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 16454026
• MDR Text Key: 310550077
• Report Number: MW5115287
• 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: Patient
• Type of Report: Initial
• Report Date: 02/23/2023

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 Model Number: 1243
• Device Catalogue Number: 1243
• Device Lot Number: CT112025
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2023
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose