MAUDE Adverse Event Report: INNOVATIVE STERILIZATION TECHNOLOGIES LLC ONE TRAY PROCESSING KIT TAMPER EVIDENT LOCKS WITH INDICATOR DOTS; WRAP CONTAINERS, TRAYS, CASSETTES AND OTHER ACCESSORIES

Model Number OTK-210

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 05/01/2019

Event Type  malfunction  

Event Description

Innovative sterilization technologies, one tray processing kit, one of two of the "tamper evident locks with indicator dots", did not transition to "black" following processing.The internal "integrator" had fully transitioned, and the "biological" test was negative.Fda safety report id# (b)(4).

• Brand Name: ONE TRAY PROCESSING KIT TAMPER EVIDENT LOCKS WITH INDICATOR DOTS
• Type of Device: WRAP CONTAINERS, TRAYS, CASSETTES AND OTHER ACCESSORIES
• Manufacturer (Section D): INNOVATIVE STERILIZATION TECHNOLOGIES LLC
• MDR Report Key: 8582401
• MDR Text Key: 144252955
• Report Number: MW5086380
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: OTK-210
• Device Catalogue Number: OTK-210
• Device Lot Number: K03180884
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1