MAUDE Adverse Event Report: 3M COMPANY 3M TRIMETRIC 1348; INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS

Model Number 1384

Device Problem Missing Information (4053)

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

Event Date 02/21/2022

Event Type  malfunction  

Event Description

3m has a new sterile processing chemical indicator 1348 for sterilization and the ifu is not available online, how are you supposed to use a product when somebody throws away the package insert and why in 2022 would a major company not have that information online.This is important for me to use it right this is patient safety we are talking about.Fda safety report id # (b)(4).

Event Description

3m has a new sterile processing chemical indicator 1348 for sterilization and the ifu is not available online, how are you supposed to use a product when somebody throws away the package insert and why in 2022 would a major company not have that information online.This is important for me to use it right this is patient safety we are talking about.Fda safety report id # (b)(4).

• Brand Name: 3M TRIMETRIC 1348
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 13600004
• MDR Text Key: 286275047
• Report Number: MW5107698
• Device Sequence Number: 1
• Product Code: JOJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other