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

Catalog Number	1432430
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	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: sterrad 100s sterilizer, (b)(4).
Event or Problem Description
A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® 100s cycle.The bi was incubated for 26 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
Asp investigation summary: the investigation included a review of the device history record (dhr), trending of 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 issues were observed in the dhr that would contribute to the complaint.Trending analysis by lot number was reviewed for the previous six months 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 analysis as the customer stated it was discarded.Thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.No problem could be found with the concomitant sterrad® 100s sterilizer.The customer indicated that the cycle completed and the subsequent three bis were negative.The customer also ran a velocity bi after the event and confirmed that the velocity bi passed, and no service was needed.The assignable cause could not be verified.It is unlikely the suspected positive bi was caused by a manufacturing issue as the retains met functional specification and dhr review found no anomalies that would contribute to a positive bi result.An issue with sterrad® performance is also unlikely as the cycle passed and the chemical indicator disc changed correctly.The customer stated subsequent bi was negative for growth.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: CYCLESURE® 24 BIOLOGICAL INDICATOR
• Common Device Name: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 8702071
• Report Number: 2084725-2019-00886
• Device Sequence Number: 2308945
• Product Code: FRC
• UDI-Device Identifier: 10705037048564
• UDI-Public: 10705037048564
• 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
• Report Date (Section B): 06/04/2019

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: 08/31/2019
• Device Catalogue Number: 1432430
• Device Lot Number: 25618083
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1