MAUDE Adverse Event Report: 3M COMPANY 3M COMPLY STERIGAGE CHEMICAL INTEGRATOR 1243A; INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS

Lot Number LC062023

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

My sterile processing department found 14 bags of 3m chemical integrators (product# 1243a, lot# lc062023) which had been flagged as part of a patient safety alert.Apparently they are causing surgical instrumentation to turn red and compromise sterility.The 14 bags have been removed and additional ones have been ordered.

• Brand Name: 3M COMPLY STERIGAGE CHEMICAL INTEGRATOR 1243A
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 12682237
• MDR Text Key: 278358237
• Report Number: MW5104883
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/20/2021
• 14 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: LC062023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1