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

Model Number 1243RE

Device Problem Problem with Sterilization (1596)

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

Event Date 12/29/2021

Event Type  malfunction  

Event Description

Trauma instrument tray was placed in sterilizer with integrator tab which did not turn and therefore instrument tray was not considered sterile for use.There was concern for faulty integrator tabs.Manufacturer response for steam integrator tab, steam chemical integrator (per site reporter).Equipment failure reported to 3m.

• Brand Name: 3M¿ ATTEST¿
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY; 3m center,2510 conway ave.; bldg. 275-5w-06; st. paul MN 55144
• MDR Report Key: 13357708
• MDR Text Key: 284449025
• Report Number: 13357708
• Device Sequence Number: 1
• Product Code: JOJ
• 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: 01/24/2022,01/20/2022

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 Model Number: 1243RE
• Device Catalogue Number: 1243RE
• Device Lot Number: SG092023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1