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

Catalog Number 14324

Device Problem Problem with Sterilization (1596)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2020

Event Type  malfunction  

Manufacturer Narrative

(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 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 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.

Manufacturer Narrative

Additional information regarding the bi: the documented incubation temperature at time of incubation was 55° c-60° c the bi was processed in single tyvek® pouch and placed on the bottom shelf of the chamber.The cap was depressed after sterrad® processing there was no reduction in media and/or leakage observed immediately after sterrad® processing there were no punctures on the side of the plastic or media leak, such as protruding glass.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, retains analysis and concomitant product evaluation.¿ trending analysis by lot number was reviewed for 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, a photograph was provided instead.The photo shows the bi cap is depressed and there is media in the vial that is yellow in color.The complaint issue is confirmed.¿ thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.¿ an issue with sterrad® unit¿s performance is unlikely since the test cycles passed and the machine parameters were normal.The assignable cause of the issue could not be verified as there is no evidence to suggest an alleged deficiency as the dhr review found no anomalies and retains analysis met specifications.A customer letter was sent to address 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: 10015065
• MDR Text Key: 190556943
• Report Number: 2084725-2020-50076
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

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: 16119028
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 04/30/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1