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

Model Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

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 35 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 affected load is released without reprocessing.

Manufacturer Narrative

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.

Manufacturer Narrative

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 06/08/2017 to 08/29/2017 and trending was not exceeded.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." one single suspect positive bis was received.The ci disc is yellow, the cap is pressed down, tyvek liner in place, and the ampoule is broken in the crushed vial.There was no media in the vial observed.There was tape placed on top of the label upon receipt.No manufacturing related anomalies observed.The reported issue cannot be confirmed with the absence of media in the vial.Thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.The likely assignable cause could be attributed to user error as the customer stated there was no issue with the sterrad; however, a new staff member was using the machine.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.Also, no manufacturing anomalies were observed in the returned suspect bi that would contribute to a positive bi result.The suspect product was returned; however, there was no media in the vial to confirm the reported issue.An issue with sterrad® performance is also unlikely as the cycle passed and the chemical indicator disc changed correctly.The customer stated subsequent bi was negative for growth.The asp fse retrained the customer over the phone on proper use to avoid any future suspect bi's in the future.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: CYCLESURE® 24 BIOLOGICAL INDICATORS
• Type of Device: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 6926061
• MDR Text Key: 89940684
• Report Number: 2084725-2017-00596
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10705037016211
• UDI-Public: (01)10705037016211(17)180430(10)15917234
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2017

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 Model Number: 14324
• Device Catalogue Number: 14324-97
• Device Lot Number: 15917234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 10/07/2017
• Supplement Dates Manufacturer Received: 10/24/2017; 07/24/2018
• Supplement Dates FDA Received: 11/14/2017; 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1