MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CYCLESURE 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	12/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: sterrad 100nx sterilizer, serial # unk.Initial reporter phone #: (b)(6).(b)(4).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).
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 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 analysis of lot number, system risk analysis (sra), visual analysis, and retains analysis.Trending analysis by lot number was reviewed within the past six months and trending was not exceeded.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.The single cyclesure® 24 bi was not returned for visual inspection.However, a photographs of the product was provided.The bi cap is depressed and the media in the vial was observed being yellow color.The complaint is confirmed.An issue with sterrad® performance is unlikely as the since the test cycles passed and the machine parameters were normal.Photos provided by the customer confirmed the complaint; however, the assignable cause could not be verified as the product was not available for return.The dhr review found no anomalies that would contribute to a positive bi result and retains testing met functional specifications.The customer was sent a letter to address the user error of releasing the load prior to reprocessing 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 92618
• MDR Report Key: 9918980
• Report Number: 2084725-2020-00028
• Device Sequence Number: 16835445
• 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): 03/11/2020

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: 03/31/2020
• Device Model Number: 14324
• Device Catalogue Number: 14324
• Device Lot Number: 13519023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1