MAUDE Adverse Event Report: INNOVATIVE STERILIZATION TECHNOLOGIES LLC ONE TRAY; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Lot Number 85280, 84997, 85289, 85894

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

We have recently obtained one tray to use in our immediate use steam sterilizer.This is used to get quicker access to instruments needed with the preface that this "one tray" would provide the rapid sterilization to terminally sterilize with in the regulatory guidelines in a pre-vacuum cycle in 4 minutes.This is completed by a filtered vent and the thermodynamic behavior of steam.These filters are labeled as hydrophobic- meaning water is to bead on them and not go through them.These filters are a one time use and are changed with each process.It was our experience that the filters had not been hydrophobic.There was apparent water at the bottom of the tray.Manufacturer response for sealed sterilization container, one tray (per site reporter): the representative came to the o.R.And watch a cycle run.Everything that staff did was appropriate and to the manufacturer's recommendations.They had suggested that this was possible due to our water quality.The same testing was completed with sterile water and it resulted in the same defect.

• Brand Name: ONE TRAY
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): INNOVATIVE STERILIZATION TECHNOLOGIES LLC; 7625 paragon rd.; ste. a; dayton OH 45459
• MDR Report Key: 6590316
• MDR Text Key: 75941270
• Report Number: 6590316
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2017,05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 85280, 84997, 85289, 85894
• Other Device ID Number: KIT NUMBER: K02170429
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2017
• Device Age: 14 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1