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

Catalog Number 14324-97

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.

Event 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) did not change color correctly.The affected load was partially released for use, and it is unclear at this time whether or not the released item was used on a patient.There was no report of infection, injury or harm to patient(s) associated with this issue.Asp will continue to follow-up for additional information and clarification.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 affected loads have been released for use without reprocessing.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

Patient identifier correction from na to unk.(b)(6).Device evaluated by manufacturer correction from no to yes.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 from 05/25/2017 to 09/25/2017 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 returned for visual inspection.The chemical indicator disc was gold in color which indicates exposure to hydrogen peroxide.There was no media remaining in the vial; however, there is purple stain remaining which does not confirm a suspect positive result.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.It is unlikely the suspected positive bi was caused by a manufacturing issue as the retains 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.An issue with sterrad® performance is also unlikely as the cycle passed and the chemical indicator disc changed correctly.The suspect bi was returned and the issue could not be confirmed.The issue will continue to be tracked and trended.(b)(4).

• Brand Name: CYCLESURE® 24 BIOLOGICAL INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 6960316
• MDR Text Key: 90637641
• Report Number: 2084725-2017-00609
• Device Sequence Number: 1
• Product Code: FRC
• 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,Followup
• Report Date: 09/26/2017

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: 04/30/2018
• Device Catalogue Number: 14324-97
• Device Lot Number: 14517228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 11/10/2017; 07/25/2018
• Supplement Dates FDA Received: 12/01/2017; 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1