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

Model Number	14324
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: sterrad 100s sterilizer, serial #: unknown.Initial reporter phone #: (b)(6).(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® 100s 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 partially 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
D4.Expiration date: correction from 3/31/2020 to 5/31/2020.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, 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 six months prior to the complaint open date and trending was not exceeded.¿ the sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." ¿ the cyclesure® 24 bi was not returned for visual inspection.¿ thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.¿ an issue with sterrad® performance is unlikely as test cycles passed and the chemical indicator disc changed correctly.The assignable cause could not be verified.It is unlikely the suspected positive bi was caused by a manufacturing issue as the retains analysis met functional specification, dhr review found no anomalies that would contribute to a positive bi result and lot history review found trending was not exceeded in this lot.The customer was sent a letter 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: 9818853
• Report Number: 2084725-2020-00021
• Device Sequence Number: 13756315
• Product Code: FRC
• UDI-Device Identifier: 10705037016211
• UDI-Public: 10705037016211
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/21/2020

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 Model Number: 14324
• Device Catalogue Number: 14324
• Device Lot Number: 16819029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1