MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100S CASSETTE; STERRAD® EQUIPMENT

Catalog Number	10113
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported using an expired sterrad® 100s cassette in a sterrad® 100s sterilizer and the load was released for use on patient(s).They stated the sterrad® did not reject the cassette and the cycle completed.The customer noticed the error when reviewing the printout on (b)(6) 2018 for a cycle cancellation of another issue.When the customer noticed the error, they immediately removed and discarded the cassette.There is no report of any infection or injury as a result of this issue.As a matter of policy, advanced sterilization products (asp) has decided to report cases where a customer reports using expired an sterrad® 100s cassette and the load has been released and used on patient(s) since sterilization cannot be guaranteed.
Additional Manufacturer Narrative
Asp investigation summary: the investigation included a review of the device batch record, trending analysis by lot number, and system risk analysis (sra).The batch record review did not reveal any indication on a deviating quality profile for this batch.No quality issues were reported.All in-process controls corresponded to the specification.Trending analysis by lot number for the issue of use of expired product - confirmed load not recalled was reviewed within the past six months and trending was not exceeded.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the customer discarded the cassette and therefore not available for evaluation.However, photos were provided which confirmed the expiration date on the cassette.While the photographs provided by the customer confirm the use of expired product, the cause of the issue is not verified since the suspect cassette was discarded by the customer.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® 100S CASSETTE
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7865550
• Report Number: 2084725-2018-00702
• Device Sequence Number: 1720239
• Product Code: MLR
• UDI-Device Identifier: 10705037014583
• UDI-Public: 10705037014583
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K991999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 10113
• Device Lot Number: 17H066
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STERRAD® 100S STERILIZER SERIAL #: (B)(4)