MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CYCLESURE BIO INDICATOR; INDICATOR, BIOLOGICAL

Catalog Number	14324
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).
Event or Problem Description
A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® 100nx cycle.The bi was incubated for 24 hours.The chemical indicator (ci) changed color correctly.The previous and subsequent bi results were both negative.The affected load was released and used on a patient.There was 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 positive cyclesure® 24 biological indicators when the load has been released and used on patient(s) prior to reprocessing.
Additional Manufacturer Narrative
Additional information regarding the bi was reported: the documented incubation temperature at time of incubation was 55° c-60° c the bi was processed in single tyvek® pouch and placed on the bottom shelf of the chamber.The cap was depressed after sterrad® processing there was no reduction in media and/or leakage observed immediately after sterrad® processing there were no punctures on the side of the plastic or media leak, such as protruding glass.H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of lot number, system risk analysis (sra), visual analysis, retains analysis and concomitant product evaluation.¿ test specifications for product release were met.No issues were observed in the release record that would contribute to the complaint.¿ trending analysis by lot number was reviewed for the six months prior to open date and trending was not exceeded.¿ the sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." ¿ the single cyclesure® 24 bi was not returned for visual inspection.However, a photograph was provided instead.The photo shows the bi cap is depressed and there is media in the vial that is yellow in color.The complaint issue is confirmed.¿ thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.¿ an issue with sterrad® unit¿s performance is unlikely since the test cycles passed and the machine parameters were normal.The assignable cause of the issue could not be verified as there is no evidence to suggest an alleged deficiency as the dhr review found no anomalies and retains analysis met specifications.The issue will continue to be tracked and trended.Asp complaint ref #: cmp-000006460.

• Brand Name: CYCLESURE BIO INDICATOR
• Common Device Name: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 10025058
• Report Number: 2084725-2020-50080
• Device Sequence Number: 2813742
• Product Code: FRC
• UDI-Device Identifier: 20705037016218
• UDI-Public: 20705037016218
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K994055
• 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): 09/22/2020

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: 05/31/2020
• Device Catalogue Number: 14324
• Device Lot Number: 16119028
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1