MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD; STERILIZER, CHEMICAL

Model Number 10133

Device Problem Material Discolored (1170)

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

Event Date 10/03/2019

Event Type  malfunction  

Event Description

The chemical indicator on the outside of our sterrad cassettes have a slight color change.The cassette's packaging indicator is meant to warn the user of risk of exposure to the sterilant contained within in the event that cassettes casing fails or becomes damaged.The color indicator strip on the side of the cassette package should remain yellow unless the cassette and the sterilant contained within are compromised.User interpretation of the slight color change in the indicator is that the cassette is questionable and should not be used.Manufacturer response for sterilant cassette, sterrad (per site reporter).Asp's technical service rep sent an email with a diagram of the acceptable color change range of the packages indicator.

• Brand Name: STERRAD
• Type of Device: STERILIZER, CHEMICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 9232960
• MDR Text Key: 163605735
• Report Number: 9232960
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10133
• Device Catalogue Number: 10133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 365 DA