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

Catalog Number	14202
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Asp investigation summary: the investigation included a review of the device history record, trending analysis by lot number, system risk analysis (sra) and supplier product investigation.The device history record was reviewed and process specifications for product release were met.No issues were observed that would contribute to the complaint.Trending analysis by lot number was reviewed from 2/6/2018 to 8/6/2018 and no significant trend was observed.The sra indicates the risk associated with exposure to toxic or corrosive material is "low.".One sterrad® sealsure ci tape retains of the same lot was subject to functional investigation by the supplier.A sterilization test was performed and the color of the ci tape changed normally from red to yellow.The assignable cause of the issue could not be confirmed; however, a likely cause could be due to the customer's load contents as subsequent use of the sealsure chemical indicator tape provided acceptable results according to the customer.Also, the supplier could not replicate the issue with the retain sample.The issue will continue to be tracked and trended.(b)(6).Asp complaint ref #: (b)(4).
Event or Problem Description
A customer initially reported the sterrad® sealsure chemical indicator tape did not change color correctly after a completed sterrad® 100s cycle.At the time of the report, it was unknown whether or not the affected load was released for use on patients prior to reprocessing.Upon follow-up with the customer on (b)(6) 2019, it was determined the load was released for use without reprocessing first.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 when the load is released for use without reprocessing first.
Additional Manufacturer Narrative
The customer will be retrained to follow the ifu which states: "if after processing, the color of the indicator is not equivalent to or lighter than the comparator bar shown in this instructions for use label, reject the cycle and resterilize all items." 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 92618
• MDR Report Key: 8464847
• Report Number: 2084725-2019-00846
• Device Sequence Number: 239689
• Product Code: FRC
• UDI-Device Identifier: 10705037016204
• UDI-Public: 10705037016204
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: 122331
• 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): 03/07/2019

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: 10/14/2019
• Device Catalogue Number: 14202
• Device Lot Number: 34817
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 03/29/2019
• 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); STERRAD® 100S STERILIZER, SERIAL # (B)(4)