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

Lot Number CW052023

Device Problems Nonstandard Device (1420); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/22/2021

Event Type  Injury  

Event Description

3m company chemical integrators have used a light red staining when used.Company issued a recall on product numbers 1243a, 1243b, 1243re.Fda safety report id # (b)(4).

• Brand Name: 3M CHEMICAL INTEGRATORS
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 12719403
• MDR Text Key: 279271722
• Report Number: MW5105015
• Device Sequence Number: 1
• Product Code: JOJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/26/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CW052023
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 68