MAUDE Adverse Event Report: 3M COMPANY, 3M HEALTHCARE ATTEST SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK; INDICATOR, BIOLOGICAL STERILIZATION PROCESS

Model Number 1492V

Device Problem Defective Device (2588)

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

Event Date 12/22/2015

Event Type  malfunction  

Event Description

The biological indicator was defective.There was not media in vial to give readout test from the incubator.Load needed to be reprocessed.

• Brand Name: ATTEST SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK
• Type of Device: INDICATOR, BIOLOGICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY, 3M HEALTHCARE; 3m center 2510 conway avenue; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 5356790
• MDR Text Key: 35513598
• Report Number: 5356790
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/01/2017
• Device Model Number: 1492V
• Device Lot Number: 2017-07AX
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/31/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1