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

Catalog Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).(b)(4).Asp complaint ref #: (b)(4).

Event Description

A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® 100nx flex cycle.The bi was incubated for 24 hours.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.

Manufacturer Narrative

Test specifications for product release were met.No issues were observed in the release record that would contribute to the complaint.Asp complaint ref #: (b)(4).

Manufacturer Narrative

Additional information received regarding bi: bi integrity was checked prior to use recommended asp product instructions were followed asp incubator was used for incubation.The bi was incubated for 24 to 72 hours.The documented incubation temperature at time of incubation was 55°c-60°c.The load was dry prior to sterrad® processing.The bi was processed in single tyvek® pouch.The bi was placed at the bottom shelf on right in the back of the chamber.The bi was at room temperature prior to sterrad® processing.The tape or a label was not placed over cyclesure¿s cap holes prior to sterrad® processing.The cap was depressed after the sterrad® processing.The bi was crushed properly using the supplied tube crusher.The bi was crushed after sterrad® processing.The ci disc color changed correctly (uniform golden or bronze) after sterrad® processing there was no reduction in media and/or leakage observed immediately after sterrad® processing.The vial was not punctured during the crushing process.The item used on a patient was a soft lens.There is no reported patient infection or injury.H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), visual analysis and retains analysis.¿ trending analysis by lot number was reviewed for the previous six months from open date and trending was not exceeded.¿ the sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." ¿ a photograph of the complaint device provided by the customer was used in lieu of product return analysis.Two (2) bis the caps are depressed and the media in the vial was observed as being yellow color.The complaint is confirmed.¿ thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.The assignable cause of the issue could not be verified.A photo of the suspected positive bi confirms the complaint issue.However, it is unlikely the complaint was caused by a manufacturing issue with cyclesure since the dhr review found no anomalies that would contribute to complaint issue, retains met specifications and lot history review did not exceed trending.A customer letter will be sent regarding the released load.The issue will continue to be tracked and trended.Asp complaint ref #: (b(4).

• Brand Name: CYCLESURE BIO INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 10001858
• MDR Text Key: 189676234
• Report Number: 2084725-2020-50055
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 20705037016218
• UDI-Public: 20705037016218
• Combination Product (y/n): N
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 14324
• Device Lot Number: 16819029
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 05/08/2020; 09/24/2020
• Supplement Dates FDA Received: 05/28/2020; 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1