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	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: (b)(6).(b)(4).
Event or Problem Description
A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® cycle.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
Regarding the suspect positive biological indicator (bi), it was reported: the bi integrity was checked prior to use; asp incubator was used for incubation; bi was incubated for 24 to 72 hours; documented incubation temperature at time of incubation was 55°c-60°c; bi was placed in single tyvek® pouch and was placed on the bottom shelf; cap was depressed after the sterrad® processing; bi was crushed after the sterrad® processing; ci color changed correctly; no reduction in media and/or leakage was observed immediately after sterrad® processing and no punctures on the side of the plastic or media leak; subsequent bi result was negative.In addition, it was reported tape or a label was placed over the bi cap holes prior to sterrad® processing.H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), photographic 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 from the six months prior to 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.However, photos were provided and show three (3) bis with the caps depressed and the media in the vials yellow in color, and one (1) bi the cap is depressed and the media in the vial is purple in color.The complaint issue is confirmed.¿ thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.The assignable cause of the suspected positive bi is likely due to user error as tape or a label was placed over cyclesure¿s cap holes prior to sterrad® processing.A customer letter is being sent to address the user error and 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 92618
• MDR Report Key: 9399099
• Report Number: 2084725-2019-01001
• Device Sequence Number: 2258710
• 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): 11/13/2019

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: 04/30/2020
• Device Model Number: 14324
• Device Catalogue Number: 14324
• Device Lot Number: 17819030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1