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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INNOVATIVE STERILIZATION TECHNOLOGIES LLC ONE TRAY; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
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INNOVATIVE STERILIZATION TECHNOLOGIES LLC ONE TRAY; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES Back to Search Results
Device Problems Degraded (1153); Material Discolored (1170); Flaked (1246)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/13/2019
Event Type  malfunction  
Event Description
The operating room department has been experiencing issues involving the one trays.The trays have been flaking off and divots from the silicone seal around the bracket which holds the filter in place during the sterilization process.There is also noted rust starting to appear on the bottom of the trays prior to use.These trays are newly purchased and have never been used.The operating room team opened an entire container of the one trays and noted all of them were compromised with rust and/or failure of the silicone seal.We have had a water-soluble test completed with results pending.The manufacturer is unsure what is causing the discoloration.Our operating room team did provide one of these trays to a local rep with no information as to their internal evaluation.The rep did bring a new tray, but it also showed signs of discoloration.No patients have been harmed from these trays/incidents.
 
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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 Key8678224
MDR Text Key147316493
Report Number8678224
Device Sequence Number1
Product Code KCT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/04/2019,03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/04/2019
Event Location Hospital
Date Report to Manufacturer06/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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