MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR; INDICATOR, BIOLOGICAL (FRC)

Catalog Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 02/04/2016

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® nx 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 not released for use.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.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), trending of the product malfunction code, trending of lot number, system risk analysis (sra), product return 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 for the product code of 'suspected positive bi" was reviewed from august 2014 through february 2015 and revealed a significant trend which was addressed through capa.Trending analysis by lot number was reviewed from 11/15/2015 to 02/15/2016 and trending was exceeded.The sra was reviewed for the issue of ¿suspect positive bi¿ with a quality problem with no impact to safety" and the risk was determined to be ¿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 yellow media remaining in the vial, confirming the suspect positive result.There were no punctures on the plastic vial or tyvek® liner which could cause a false positive from external contamination.No manufacturing related anomalies observed.Thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.It is unlikely the suspected positive bi was caused by a manufacturing issue as the retains met functional specification and dhr review found no anomalies that would contribute to a positive bi result.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 cyclesure® retains met functional specification.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.

• Brand Name: STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL (FRC)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; irvine, CA 92618
• MDR Report Key: 5469080
• MDR Text Key: 39546005
• Report Number: 2084725-2016-00110
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2016

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: 04/30/2016
• Device Catalogue Number: 14324
• Device Lot Number: 32115305
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1