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

Catalog Number	14202
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant med products: sterrad® 100s sterilizer, serial # (b)(4).(b)(6).(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.The affiliate did confirm, however, that the ci on the biological indicator changed correctly.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
Patient codes correction from 2692 to 2199.New information reported in a 3500a supplemental report on 8/22/2019 indicated the load was reprocessed prior to being released for use on patients which makes this event no longer a reportable malfunction since there is no longer any risk to patients.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
It was originally reported in the initial report that the load was released for use on patients without reprocessing first.Upon follow-up, the customer confirmed the load was reprocessed prior to being released for use for use on patients.The customer confirmed the ci tape was not overlapping and the load was not over packed.Asp complaint ref #: (b)(4).

• Brand Name: SEALSURE CI TAPE CASE
• Common Device Name: INDICATOR, CHEMICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 8839629
• Report Number: 2084725-2019-00916
• Device Sequence Number: 2742504
• Product Code: FRC
• UDI-Device Identifier: 10705037016204
• UDI-Public: 10705037016204
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 07/11/2019

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 Catalogue Number: 14202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 07/30/2019; 09/26/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/22/2019; 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1