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

Lot Number RE092022

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/29/2020

Event Type  malfunction  

Event Description

Test pack chemical integrator did not achieve "accept" range during sterilization.Biological was tested and resulted negative.Fda safety report id# (b)(4).

• Brand Name: CHEMICAL INTEGRATOR
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 11125210
• MDR Text Key: 225509017
• Report Number: MW5098679
• 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: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: RE092022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1