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	04/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant med product: sterrad 100nx sterilizer, serial # (b)(4).(b)(4).Asp complaint ref #: (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 two 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
Test specifications for product release were met.No issues were observed in the dhr that would contribute to the complaint.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), visual analysis and retains analysis.¿ the dhr was reviewed and the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer's experienced issue.¿ trending analysis by lot number was reviewed for the previous six months from 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, and therefore, visual analysis could not be performed.¿ thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.The assignable cause of the issue could not be verified.The dhr review found no anomalies that would contribute to the complaint issue and retains testing met specification.However, the product was not returned so no further analysis could be performed.A customer letter was sent addressing the released load.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: CYCLESURE BIO INDICATOR
• Common Device Name: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 10014447
• Report Number: 2084725-2020-50079
• Device Sequence Number: 2715365
• Product Code: FRC
• UDI-Device Identifier: 20705037016218
• UDI-Public: 20705037016218
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K994055
• 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,Followup
• Report Date (Section B): 09/23/2020

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: 12/31/2020
• Device Catalogue Number: 14324
• Device Lot Number: 01420002
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 05/01/2020; 09/18/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 05/21/2020; 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1