MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CYCLESURE® 24 BIO INDICATOR; INDICATOR, BIOLOGICAL

Catalog Number	14324
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: sterrad® nx sterilizer, serial # (b)(4).(b)(4).
Event or Problem Description
A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® nx cycle.The bi was incubated for 24.5 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 two patients.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
Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis by lot number, system risk analysis (sra), visual analysis, retains analysis and concomitant product evaluation.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 from 12/11/2018 to 05/09/2019 and trending was not exceeded.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." two (2) cyclesure® 24 bi¿s were returned.One (1) disc is red, the cap is depressed, the vial is crushed and there is dried yellow media in vial.One (1) disc is gold, the cap is depressed, the vial is crushed and there is yellow media in vial.The reason for the return is confirmed.Thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.An issue with sterrad® performance is unlikely as the cycle passed and the chemical indicator disc changed correctly.Additionally, the previous and subsequent bi¿s were negative for growth.The returned used product confirmed a suspect positive bi through a visual analysis.However, there is no evidence to suggest an alleged deficiency as the dhr review found no anomalies that would contribute to a positive bi result, retains product met function specification and lot history review found trending was not exceeded in this lot.There is no evidence that the reported issue was related to the sterrad® nx performance as the cycle passed, the ci disc changed color correctly, and the customer indicated that the previous and subsequent bis were negative for growth.Therefore, the assignable cause cannot be verified.A customer letter was sent to address the released load.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: CYCLESURE® 24 BIO INDICATOR
• Common Device Name: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 8629903
• Report Number: 2084725-2019-00877
• Device Sequence Number: 11351466
• Product Code: FRC
• UDI-Device Identifier: 10705037016211
• UDI-Public: 10705037016211
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 05/10/2019

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: 11/30/2019
• Device Catalogue Number: 14324
• Device Lot Number: 34518106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1