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

Catalog Number 14324-97

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/15/2017

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 failed bi was placed on the bottom shelf at the back of the chamber.A second bi was placed on the top shelf at the back of the chamber and did not fail.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 loads have been released without reprocessing.

Manufacturer Narrative

Returned to manufacturer: correction from no to yes.Concomitant medical products: corrected from sterrad® 100s (serial # (b)(4)) to sterrad® 100s (serial # (b)(4)).Corrections: initial reporter name: change from (b)(6).Initial reporter last name: change from (b)(6).Initial reporter facility name: change from (b)(6) hospital initial reporter email: change from (b)(6) to blank.Initial reporter phone: (b)(6).

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.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.Trending analysis by lot number was reviewed from 06/02/2017 to 09/19/2017 and trending was not exceeded.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." two (2) suspect positive bis were received.The ci disc was yellow, the cap was pressed down, tyvek liner in place, and the ampoule is broken in the crushed vial.There was no media in the vials observed to confirm the issue.No manufacturing related anomalies observed.Thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.The assignable cause 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.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 chemical indicator disc changed correctly.The customer stated subsequent bi was negative for growth.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: CYCLESURE® 24 BIOLOGICAL INDICATOR
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 6937820
• MDR Text Key: 90058660
• Report Number: 2084725-2017-00601
• 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: 09/15/2017

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: 15317231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 09/15/2017; 07/10/2018
• Supplement Dates FDA Received: 12/19/2017; 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1