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

Model Number 1233LF

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2019

Event Type  malfunction  

Event 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¿
• Type of Device: 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
• MDR Text Key: 139550470
• Report Number: 8443242
• Device Sequence Number: 1
• Product Code: JOJ
• UDI-Device Identifier: 50707387584158
• UDI-Public: (01)50707387584158(170210107(10)202101CH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 1233LF
• Device Catalogue Number: 1233LF
• Device Lot Number: 202101CH
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2019
• Type of Device Usage: N
• Patient Sequence Number: 1