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

Model Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).(b)(4).

Event Description

A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® 100s short cycle.The bi was incubated for 24 hours.The chemical indicator (ci) changed color correctly.A subsequent bi was negative.The affected load was released and used on patient(s).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 loads have not been reprocessed.

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, retains analysis and concomitant product evaluation.¿ trending analysis by lot number was reviewed from 05/25/2017 to 10/10/2017 and trending was not exceeded.¿ the sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." ¿ an issue with the concomitant sterrad® 100s is unlikely since the cycle passed and the ci disc changed color correctly.Additionally, the asp field service engineer serviced the unit and confirmed it was working within specifications.The assignable cause could not be verified.It is unlikely the suspected positive bi was caused by a manufacturing issue as the cyclesure® 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.An issue with sterrad® performance is also unlikely as the cycle passed and the customer stated subsequent bi was negative for growth.As a result, there is not an issue with product performance when used per the instructions for use (ifu).The issue will continue to be tracked and trended.

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.The single cyclesure 24 bi was returned for visual inspection.The ci disc is yellow which indicates exposure to hydrogen peroxide, the cap is pressed down, the vial is crushed, and there is yellow media in the vial.The suspected positive growth result was observed.No manufacturing related anomalies observed.Thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.

• Brand Name: CYCLESURE® 24 BIOLOGICAL INDICATOR
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ASP IRVINE MFG; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6982680
• MDR Text Key: 90860206
• Report Number: 2084725-2017-00637
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10705037016211
• UDI-Public: (01)10705037016211(17)180430(10)14517228
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2017

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: 14517228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 11/30/2017; 01/03/2018; 03/28/2018
• Supplement Dates FDA Received: 12/05/2017; 01/19/2018; 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1