MAUDE Adverse Event Report: INNOVATIVE STERILIZATION TECHN ONETRAY; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Device Problem Inaccurate Information (4051)

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

Event Type  malfunction  

Event Description

The instructions for use for the onetray system provided by innovative sterilization technologies has misleading information about storage that can lead to patient harm.In one section it states 2 days storage life, and in another area it says "event related shelf life" "follow facility policies and procedures".This leads healthcare professionals to believe it has event related shelf life when it does not.This can cause severe patient harm if hospitals store these items from the confusion of this ifu.Fda safety report id # (b)(4).

• Brand Name: ONETRAY
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): INNOVATIVE STERILIZATION TECHN
• MDR Report Key: 11378025
• MDR Text Key: 233813630
• Report Number: MW5099622
• Device Sequence Number: 1
• Product Code: KCT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1