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

Model Number	1233LF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Reported that the bowie dick comply test failed 4 times in 3 different sterilizers.All tests came from the same box with the same lot #.After each failure, each sterilizer was inspected/examined by the manufacturer's service technician.The technician found nothing wrong with any of the 3 sterilizers and recommended that the bowie dick test from a different lot # be run in all 3 autoclaves.This was done and all three passed.

• Brand Name: COMPLY¿
• Common Device Name: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave.; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 8443242
• Report Number: 8443242
• Device Sequence Number: 19564628
• Product Code: JOJ
• UDI-Device Identifier: 50707387584158
• UDI-Public: (01)50707387584158(170210107(10)202101CH
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2019
• Report Date (Section F): 03/08/2019

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
• Operator of Device: No Information
• Device Model Number: 1233LF
• Device Catalogue Number: 1233LF
• Device Lot Number: 202101CH
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/08/2019