MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD SEALSURE CI TAPE; INDICATOR, CHEMICAL

Catalog Number	14202
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).
Event or Problem Description
A customer reported the sterrad® sealsure chemical indicator tape did not change color correctly after a completed sterrad® 100s cycle and the affected load was released for use on patients prior to reprocessing.There is no report of infection, injury or harm to patient(s) associated with this issue.Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined in this situation sterility cannot be assured.Therefore, as a matter of policy asp had decided to report all incidents of sterrad® sealsure chemical indicator tape not changing color correctly.
Additional Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the device history record (dhr), complaint trending by lot number, system risk analysis (sra), visual analysis and concomitant product evaluation.Dhr was not performed as the lot number was not available.Complaint trending by lot number was not performed since the lot number was not available.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." an asp field service engineer (fse) was dispatched to the site and ran a test cycle on the sterrad 100s sterilizer and was unable to duplicate the issue.The cycle completed successfully and no problem could be found.The ci tape was not available for return; therefore, no visual analysis could be performed.The assignable cause of the issue could not be determined as there is insufficient information provided by the customer to determine the cause.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD SEALSURE CI TAPE
• Common Device Name: INDICATOR, CHEMICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 10836858
• Report Number: 2084725-2020-50273
• Device Sequence Number: 19640953
• Product Code: FRC
• UDI-Device Identifier: 20705037016201
• UDI-Public: 20705037016201
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: 122331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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 Catalogue Number: 14202
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1